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Continuous support for women during childbirth (Review)

Hodnett ED, Gates S, Hofmeyr GJ, Sakala C, Weston J

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2011, Issue 2

http://www.thecochranelibrary.com

Continuous support for women during childbirth (Review)

http://www.thecochranelibrary.com

T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

13DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Analysis 1.1. Comparison 1 Continuous support versus usual care - all trials, Outcome 1 Any analgesia/anaesthesia. . 51 Analysis 1.2. Comparison 1 Continuous support versus usual care - all trials, Outcome 2 Regional analgesia/anaesthesia. 52 Analysis 1.3. Comparison 1 Continuous support versus usual care - all trials, Outcome 3 Synthetic oxytocin during

labour. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Analysis 1.4. Comparison 1 Continuous support versus usual care - all trials, Outcome 4 Labour length. . . . . . 54 Analysis 1.5. Comparison 1 Continuous support versus usual care - all trials, Outcome 5 Spontaneous vaginal birth. 55 Analysis 1.6. Comparison 1 Continuous support versus usual care - all trials, Outcome 6 Instrumental vaginal birth. 56 Analysis 1.7. Comparison 1 Continuous support versus usual care - all trials, Outcome 7 Caesarean birth. . . . . 57 Analysis 1.8. Comparison 1 Continuous support versus usual care - all trials, Outcome 8 Perineal trauma. . . . . 58 Analysis 1.9. Comparison 1 Continuous support versus usual care - all trials, Outcome 9 Low 5-minute Apgar score. 59 Analysis 1.10. Comparison 1 Continuous support versus usual care - all trials, Outcome 10 Admission to special care

nursery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Analysis 1.11. Comparison 1 Continuous support versus usual care - all trials, Outcome 11 Prolonged neonatal hospital

stay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Analysis 1.12. Comparison 1 Continuous support versus usual care - all trials, Outcome 12 Postpartum report of severe

labour pain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Analysis 1.13. Comparison 1 Continuous support versus usual care - all trials, Outcome 13 Negative rating of/negative

feelings about birth experience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Analysis 1.14. Comparison 1 Continuous support versus usual care - all trials, Outcome 14 Difficulty mothering. . 63 Analysis 1.15. Comparison 1 Continuous support versus usual care - all trials, Outcome 15 Breastfeeding at 1-2 months

postpartum. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Analysis 1.16. Comparison 1 Continuous support versus usual care - all trials, Outcome 16 Postpartum depression. . 64 Analysis 1.17. Comparison 1 Continuous support versus usual care - all trials, Outcome 17 Low postpartum self-esteem. 64 Analysis 2.1. Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 1

Any analgesia/anaesthesia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Analysis 2.2. Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 2

Synthetic oxytocin during labour. . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 Analysis 2.3. Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 3

Spontaneous vaginal birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Analysis 2.4. Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 4

Caesarean birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 Analysis 2.5. Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 5

Admission to special care nursery. . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Analysis 2.6. Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 6

Postpartum depression. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

iContinuous support for women during childbirth (Review)

Analysis 2.7. Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 7 Negative rating of/negative feelings about birth experience. . . . . . . . . . . . . . . . . . . 71

Analysis 2.8. Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 8 Breastfeeding at 1-2 months postpartum. . . . . . . . . . . . . . . . . . . . . . . . . 72

Analysis 3.1. Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 1 Any analgesia/anaesthesia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Analysis 3.2. Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 2 Synthetic oxytocin during labour. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Analysis 3.3. Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 3 Spontaneous vaginal birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Analysis 3.4. Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 4 Caesarean birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Analysis 3.5. Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 5 Admission to special care nursery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Analysis 3.6. Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 6 Postpartum depression. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Analysis 3.7. Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 7 Negative rating of/negative feelings about birth experience. . . . . . . . . . . . . . . . . . . . . . 79

Analysis 3.8. Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 8 Breastfeeding at 1-2 months postpartum. . . . . . . . . . . . . . . . . . . . . . . . . 80

Analysis 4.1. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 1 Any analgesia/anaesthesia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Analysis 4.2. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 2 Synthetic oxytocin during labour. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Analysis 4.3. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 3 Spontaneous vaginal birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Analysis 4.4. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 4 Caesarean birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Analysis 4.5. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 5 Admission to special care nursery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Analysis 4.6. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 6 Postpartum depression. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Analysis 4.7. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 7 Negative rating of /negative views about birth experience. . . . . . . . . . . . . . . . . . . . . . . . . 88

Analysis 4.8. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 8 Breastfeeding at 1-2 months postpartum. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Analysis 5.1. Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 1 Any analgesia/anaesthesia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Analysis 5.2. Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 2 Synthetic oxytocin during labour. . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Analysis 5.3. Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 3 Spontaneous vaginal birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Analysis 5.4. Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 4 Caesarean birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Analysis 5.5. Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 5 Admission to special care nursery. . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Analysis 5.6. Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 6 Postpartum depression. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Analysis 5.7. Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 7 Negative rating of/negative feelings about birth experience. . . . . . . . . . . . . . . . . . . 97

Analysis 5.8. Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 8 Breastfeeding at 1-2 months postpartum. . . . . . . . . . . . . . . . . . . . . . . . . 98

98WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iiContinuous support for women during childbirth (Review)

99HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

100INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iiiContinuous support for women during childbirth (Review)

[Intervention Review]

Continuous support for women during childbirth

Ellen D Hodnett1, Simon Gates2, G Justus Hofmeyr3, Carol Sakala4, Julie Weston1

1Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada. 2Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK. 3Department of Obstetrics and Gynaecology, East London Hospital Complex, University of the Witwatersrand, University of Fort Hare, Eastern Cape Department of Health, East London, South Africa. 4Childbirth Connection, New York, USA

Contact address: Ellen D Hodnett, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, Ontario, M5T 1P8, Canada. [email protected].

Editorial group: Cochrane Pregnancy and Childbirth Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 2, 2011. Review content assessed as up-to-date: 9 January 2011.

Citation: Hodnett ED, Gates S, Hofmeyr GJ, Sakala C, Weston J. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews 2011, Issue 2. Art. No.: CD003766. DOI: 10.1002/14651858.CD003766.pub3.

A B S T R A C T

Background

Historically, women have been attended and supported by other women during labour. However in hospitals worldwide, continuous support during labour has become the exception rather than the routine.

Objectives

Primary: to assess the effects of continuous, one-to-one intrapartum support compared with usual care. Secondary: to determine whether the effects of continuous support are influenced by: (1) routine practices and policies; (2) the provider’s relationship to the hospital and to the woman; and (3) timing of onset.

Search strategy

We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (31 December 2010).

Selection criteria

All published and unpublished randomized controlled trials comparing continuous support during labour with usual care.

Data collection and analysis

We used standard methods of the Cochrane Collaboration Pregnancy and Childbirth Group. Two authors independently evaluated methodological quality and extracted the data. We sought additional information from the trial authors. We used random-effects analyses for comparisons in which high heterogeneity was present, and we reported results using the risk ratio for categorical data and mean difference for continuous data.

Main results

Twenty-one trials involving 15061 women met inclusion criteria and provided usable outcome data. Results are of random-effects analyses, unless otherwise noted. Women allocated to continuous support were more likely to have a spontaneous vaginal birth (RR 1.08, 95% CI 1.04 to 1.12) and less likely to have intrapartum analgesia (RR 0.90, 95% CI 0.84 to 0.97) or to report dissatisfaction (RR 0.69, 95% CI 0.59 to 0.79). In addition their labours were shorter (mean difference -0.58 hours, 95% CI -0.86 to -0.30), they were less likely to have a caesarean (RR 0.79, 95% CI 0.67 to 0.92) or instrumental vaginal birth (fixed-effect, RR 0.90, 95% CI

1Continuous support for women during childbirth (Review)

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0.84 to 0.96), regional analgesia (RR 0.93, 95% CI 0.88 to 0.99), or a baby with a low 5-minute Apgar score (fixed-effect, RR 0.70, 95% CI 0.50 to 0.96). There was no apparent impact on other intrapartum interventions, maternal or neonatal complications, or on breastfeeding. Subgroup analyses suggested that continuous support was most effective when provided by a woman who was neither part of the hospital staff nor the woman’s social network, and in settings in which epidural analgesia was not routinely available. No conclusions could be drawn about the timing of onset of continuous support.

Authors’ conclusions

Continuous support during labour has clinically meaningful benefits for women and infants and no known harm. All women should have support throughout labour and birth.

P L A I N L A N G U A G E S U M M A R Y

Continuous support for women during childbirth

Continuous support in labour increased the chance of a spontaneous vaginal birth, had no harm, and women were more satisfied.

Historically women have been attended and supported by other women during labour and birth. However in many countries, as more women are giving birth in hospital rather than at home, continuous support during labour has become the exception rather than the norm. This may contribute to the dehumanization of women’s childbirth experiences. Modern obstetric care frequently subjects women to institutional routines, which may have adverse effects on the progress of labour. Supportive care during labour may involve emotional support, comfort measures, information and advocacy. These may enhance physiologic labour processes as well as women’s feelings of control and competence, and thus reduce the need for obstetric intervention. The review of studies included 21 trials, from 15 countries, involving more than 15,000 women in a wide range of settings and circumstances. The continuous support was provided either by hospital staff (such as nurses or midwives), women who were not hospital employees and had no personal relationship to the labouring woman (such as doulas or women who were provided with a modest amount of guidance), or by companions of the woman’s choice from her social network (such as her husband, partner, mother, or friend). Women who received continuous labour support were more likely to give birth ’spontaneously’, i.e. give birth with neither caesarean nor vacuum nor forceps. In addition, women were less likely to use pain medications, were more likely to be satisfied, and had slightly shorter labours. Their babies were less likely to have low 5-minute Apgar Scores. No adverse effects were identified. We conclude that all women should have continuous support during labour. Continuous support from a person who is present solely to provide support, is not a member of the woman’s social network, is experienced in providing labour support, and has at least a modest amount of training, appears to be most beneficial. Support from a chosen family member or friend appears to increase women’s satisfaction with their childbearing experience.

B A C K G R O U N D

The first version of this Cochrane Review was published in 1995 (Hodnett 2003) when the first systematic reviews in the Cochrane Collaboration Pregnancy and Childbirth Group Mod- ule were converted to the Cochrane Review format. Thus a formal Cochrane Protocol was not initially published. Subsequently the Review author, Ellen Hodnett, completed a trial of labour support (Hodnett 2002) with a sample size larger than the entire sample in the prior version of the original Review. As a protection against bias, she sought co-authors who were blind to the results of the new trial and who had special expertise that would enhance the quality of the Review. Discussions among the authors led to de- cisions to modify the background and methods. The authors de-

cided that the best approach would be to write a new Protocol for the Review. The new Protocol was submitted through the peer review process of the Cochrane Pregnancy and Childbirth Group and has subsequently evolved into a Review that has been updated.

Historically and cross-culturally, women have been attended and supported by other women during labour and birth. However, since the middle of the 20th century, in many countries as the ma- jority of women gave birth in hospital rather than at home, contin- uous support during labour has become the exception rather than the routine. Concerns about dehumanization of women’s birth ex- periences (in high-, middle-, and low income countries) have led to calls for a return to continuous, one-to-one support by women

2Continuous support for women during childbirth (Review)

for women during labour (Klaus 2002). Common elements of this care include emotional support (continuous presence, reassur- ance and praise), information about labour progress and advice re- garding coping techniques, comfort measures (such as comforting touch, massage, warm baths/showers, promoting adequate fluid intake and output) and advocacy (helping the woman articulate her wishes to others).

Two complementary theoretical explanations have been offered for the effects of labour support on childbirth outcomes. Both ex- planations hypothesize that labour support enhances labour phys- iology and mothers’ feelings of control and competence, reducing reliance on medical interventions. The first theoretical explana- tion considers possible mechanisms when companionship during labour is used in stressful, threatening and disempowering clini- cal birth environments (Hofmeyr 1991). During labour women may be uniquely vulnerable to environmental influences; modern obstetric care frequently subjects women to institutional routines, high rates of intervention, unfamiliar personnel, lack of privacy and other conditions that may be experienced as harsh. These con- ditions may have an adverse effect on the progress of labour and on the development of feelings of competence and confidence; this may in turn impair adjustment to parenthood and establishment of breastfeeding, and increase the risk of depression. The provision of support and companionship during labour may to some extent buffer such stressors.

The second theoretical explanation does not focus on a particular type of birth environment. Rather, it describes two pathways - enhanced passage of the fetus through the pelvis and soft tissues, as well as decreased stress response - by which labour support may reduce the likelihood of operative birth and subsequent compli- cations, and enhance women’s feelings of control and satisfaction with their childbirth experiences (Hodnett 2002a). Enhanced fe- topelvic relationships may be accomplished by encouraging mo- bility and effective use of gravity, supporting women to assume their preferred positions and recommending specific positions for specific situations. Studies of the relationships among fear and anx- iety, the stress response and pregnancy complications have shown that anxiety during labour is associated with high levels of the stress hormone epinephrine in the blood, which may in turn lead to ab- normal fetal heart rate patterns in labour, decreased uterine con- tractility, a longer active labour phase with regular well-established contractions and low Apgar scores (Lederman 1978; Lederman 1981). Emotional support, information and advice, comfort mea- sures and advocacy may reduce anxiety and fear and associated adverse effects during labour.

Continuous support has been viewed by some as a form of pain re- lief, specifically, as an alternative to epidural analgesia (Dickinson 2002), because of concerns about the deleterious effects of epidural analgesia on labour progress (Anim-Somuah 2005). Many labour and birth interventions routinely involve, or increase the like- lihood of, co-interventions to monitor, prevent or treat adverse

effects, in a “cascade of interventions”. Continuous, one-to-one support has the potential to limit this cascade and therefore to have a broad range of different effects, in comparison to usual care. For example, if continuous support leads to reduced use of epidural analgesia, it may in turn involve less use of electronic fetal monitoring, intravenous drips, synthetic oxytocin, drugs to combat hypotension, bladder catheterization, vacuum extraction or forceps, episiotomy and less morbidity associated with these, and may increase mobility during labour and spontaneous birth (Caton 2002).

A systematic review examining factors associated with women’s sat- isfaction with the childbirth experience suggests that continuous support can make a substantial contribution to this satisfaction. When women evaluate their experience, four factors predominate: the amount of support from caregivers, the quality of relationships with caregivers, being involved with decision-making and having high expectations or having experiences that exceed expectations (Hodnett 2002a).

Clarification of the effects of continuous support during labour, overall and within specific circumstances, is important in light of public and social policies and programs that encourage this type of care. For example, the Congress in Uruguay passed a law in 2001 decreeing that all women have the right to companionship during labour. In several low- and middle-income countries (including China, South Africa, Tanzania and Zimbabwe), the Better Births Initiative promotes labour companionship as a core element of care for improving maternal and infant health (WHO 2010). In many low income countries, women are not permitted to have anyone with them during labour and birth. Efforts to change policies in these settings have led to questions about the effectiveness of support from husbands/partners or other support people of the woman’s own choosing, particularly in settings where the cost of paid companions would be prohibitive.

In North America, the services of women with special training in labour support have become available. Most commonly known as doula (a Greek word for ’handmaiden’), this new member of the caregiver team may also be called a labour companion, birth companion, labour support specialist, labour assistant or birth as- sistant. A number of North American organizations offer doula training, certification and professional support; according to one estimate more than 50,000 people have received this training to date (P Simkin, personal communication). Some North American hospitals have begun to sponsor doula services. In recent national surveys of childbearing women in the United States, 3% to 5% of respondents indicated that they had used doula services during their most recent labours (Declercq 2002; Declercq 2006). An association for doulas has been established in the UK (McGinnis 2001). Maternal healthcare systems in dozens of high- and low- to middle-income countries throughout the world are develop- ing new traditions for supportive female companionship during labour (Pascali-Bonaro 2010).

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Questions have arisen about the ability of employees (such as nurses or midwives) to provide effective labour support, in the con- text of modern institutional birth environments (Hodnett 1997). For example, nurses and midwives often have simultaneous re- sponsibility for more than one labouring woman, spend a large proportion of time managing technology and keeping records, and begin or end work shifts in the middle of women’s labours. They may lack labour support skills or may work in short-staffed en- vironments. Companions, such as husbands/partners and female relatives, usually have little experience in providing labour support and are themselves in need of support when with a loved one dur- ing labour and birth. In addition to questions about the impact of the type of provider of labour support, there are other questions about the effectiveness of support, including its impact under a variety of environmental conditions, and whether its effects are mediated by when continuous support begins (early versus active labour).

Childbearing women, policy-makers, payers of health services, health professionals and facilities and those who provide labour support all need evidence about the effects of continuous support, overall and under specific conditions.

The current update includes new trials and major revisions to all aspects of the Review, to align it with current Cochrane method- ological guidelines (Higgins 2009).

O B J E C T I V E S

The primary objective was to assess the effects, on mothers and their babies, of continuous, one-to-one intrapartum support com- pared with usual care, in any setting. Secondary objectives were to determine whether the effects of continuous support are influ- enced by:

(1) routine practices and policies in the birth environment that may affect a woman’s autonomy, freedom of movement and ability to cope with labour, including:

(a) policies about the presence of support people of the woman’s own choosing;

(b) epidural analgesia; and

(2) whether the provider is a) a member of the staff of the institu- tion (and thus has additional loyalties or responsibilities), b) not a staff member but not part of the woman’s social network, or c) or a person chosen by the woman from family members and friends; and

(3) whether the continuous support begins early or later in labour.

M E T H O D S

Criteria for considering studies for this review

Types of studies

All controlled trials comparing continuous labour support by ei- ther a familiar or unfamiliar person (with or without healthcare professional qualifications) with usual care, in which there was random allocation to treatment and control groups, were consid- ered for inclusion in the Review.

Types of participants

Pregnant women, in labour.

Types of interventions

The form of care that was evaluated was continuous presence and support during labour and birth. The person providing the sup- port could have qualifications as a healthcare professional (nurse, midwife) or training as a doula or childbirth educator, or be a family member, spouse/partner, friend or stranger with little or no special training in labour support. The control group received usual care, as defined by the trialists. In all cases, ’usual care’ did not involve continuous intrapartum support, but it could involve other measures, such as routine epidural analgesia, to help women to cope with labour.

Types of outcome measures

Theoretically continuous support can have many diverse physio- logical and psychosocial effects (both short- and long-term), and therefore a larger than usual number of outcomes were considered.

Primary outcomes

Mother

1. Any analgesia/anaesthesia (pain medication) 2. Synthetic oxytocin during labour 3. Spontaneous vaginal birth 4. Postpartum depression (defined using a pre-specified cutoff

score on a validated instrument) 5. Negative rating of/negative feelings about the birth

experience Baby

1. Admission to special care nursery 2. Breastfeeding at 1-2 months postpartum

Secondary outcomes

Labour events

1. Regional analgesia/anaesthesia 2. Labour length

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3. Severe labour pain (postpartum report) Birth

1. Caesarean birth 2. Instrumental vaginal birth 3. Perineal trauma (defined as episiotomy or laceration

requiring suturing) Newborn

1. Low five-minute Apgar score (as defined by trial authors) 2. Prolonged newborn hospital stay

Longer-term maternal outcomes

1. Difficulty mothering 2. Low self-esteem in the postpartum period

Search methods for identification of studies

Electronic searches

We searched the Cochrane Pregnancy and Childbirth Group’s Tri- als Register by contacting the Trials Search Co-ordinator (31 De- cember 2010). The Cochrane Pregnancy and Childbirth Group’s Trials Register is maintained by the Trials Search Co-ordinator and contains trials identified from:

1. quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);

2. weekly searches of MEDLINE; 3. handsearches of 30 journals and the proceedings of major

conferences; 4. weekly current awareness alerts for a further 44 journals

plus monthly BioMed Central email alerts. Details of the search strategies for CENTRAL and MEDLINE, the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service can be found in the ‘Specialized Register’ section within the edito- rial information about the Cochrane Pregnancy and Childbirth Group. Trials identified through the searching activities described above are each assigned to a review topic (or topics). The Trials Search Co-ordinator searches the register for each review using the topic list rather than keywords. We did not apply any language restrictions.

Data collection and analysis

For this update we re-assessed all trials (both those already in the review and the reports identified by the updated search), using the following methods.

Selection of studies

For the current update, two review authors (EH and JW) indepen- dently assessed for inclusion all potentially eligible studies. Had any disagreement occurred, we would have resolved it through dis- cussion or, if required, we would have consulted a third member of the review team.

Data extraction and management

We designed a form to extract data. For eligible studies, two review authors (EH, JW) extracted the data using the agreed form. We resolved discrepancies through discussion. We entered data into Review Manager software (RevMan 2008) and checked for accu- racy. When information regarding any of the above was unclear, we attempted to contact authors of the original reports to provide further details.

Assessment of risk of bias in included studies

Two review authors (EH, JW) independently assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2009). We would have resolved any disagreement by discussion or by involving a third assessor.

(1) Sequence generation (checking for possible selection

bias)

We described for each included study the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups. We assessed the method as:

• adequate (any truly random process, e.g. random number table; computer random number generator),

• inadequate (any non-random process, e.g. odd or even date of birth; hospital or clinic record number) or,

• unclear.

(2) Allocation concealment (checking for possible selection

bias)

We described for each included study the method used to conceal the allocation sequence, and determined whether intervention al- location could have been foreseen in advance of, or during recruit- ment, or changed after assignment. We assessed the methods as:

• adequate (e.g. telephone or central randomization; consecutively numbered sealed opaque envelopes);

• inadequate (open random allocation; unsealed or non- opaque envelopes, alternation; date of birth);

• unclear.

5Continuous support for women during childbirth (Review)

http://www.mrw.interscience.wiley.com/cochrane/clabout/articles/PREG/frame.html

(3) Blinding (checking for possible performance bias)

We described for each included study the methods used, if any, to blind personnel from knowledge of which intervention a partici- pant received. Since women and care providers cannot be blinded as to whether continuous support was given, we considered blind- ing adequate if outcomes were recorded by outcome assessors who had no knowledge of the woman’s group assignment. We judged studies at low risk of bias if they were blinded, or if we judged that the lack of blinding could not have affected the results. We assessed blinding separately for different outcomes or classes of outcomes.

4) Incomplete outcome data (checking for possible attrition

bias through withdrawals, dropouts, protocol deviations)

We described for each included study, and for each outcome or class of outcomes, the completeness of data including attrition and exclusions from the analysis. We stated whether attrition and exclusions were reported, the numbers included in the analysis at each stage (compared with the total randomized participants), rea- sons for attrition or exclusion where reported, and whether miss- ing data were balanced across groups or were related to outcomes. To be included in the review, data on a given outcome had to be available for at least 80% of those who were originally randomized. For outcomes collected post hospital discharge, we recognize that follow-up, particularly in low-income countries, can be very dif- ficult. Therefore, we included data if the response rate was higher than 75% and there was no obvious imbalance in groups. Where sufficient information was reported, or could be supplied by the trial authors, we planned to include missing data in the analyses. We assessed methods as:

• adequate; • inadequate; • unclear.

(5) Selective reporting bias

We described for each included study how we investigated the possibility of selective outcome reporting bias and what we found. We assessed the methods as:

• adequate (where it is clear that all of the study’s pre- specified outcomes and all expected outcomes of interest to the review have been reported);

• inadequate (where not all the study’s pre-specified outcomes have been reported; one or more reported primary outcomes were not pre-specified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported);

• unclear.

(6) Other sources of bias

We planned to describe for each included study any important concerns we had about other possible sources of bias, including, for example, whether the trial was stopped early due to a data- dependent process, there was evidence of extreme baseline imbal- ance, or there had been claims of fraud.

We assessed whether each study was free of other problems

that could put it at risk of bias:

• yes; • no; • unclear.

(7) Overall risk of bias

We made explicit judgements about whether studies are at high risk of bias, according to the criteria given in the Handbook (Higgins 2009). With reference to (1) to (6) above, we assessed the likely magnitude and direction of the bias and whether we considered it is likely to impact on the findings. We explored the impact of the level of bias through undertaking sensitivity analyses - see ’ Sensitivity analysis’

Measures of treatment effect

Dichotomous data

For dichotomous data, we presented results as summary risk ratio with 95% confidence intervals.

Continuous data

All but one pre-specified outcome involved dichotomous data. For labour length, we used the mean difference because it was measured in the same way in the trials.

Unit of analysis issues

Cluster-randomized trials

Had we found cluster-randomized trials, we would have included them in the analyses along with individually randomized trials. Our plan was as follows: we would adjust their sample sizes or standard errors using the methods described in the Handbook (Sec- tion 16.3.4 or 16.3.6) using an estimate of the intracluster corre- lation co-efficient (ICC) derived from the trial (if possible), from a similar trial or from a study of a similar population. If we use ICCs from other sources, we will report this and conduct sensitiv- ity analyses to investigate the effect of variation in the ICC. If we identify both cluster-randomized trials and individually-random- ized trials, we plan to synthesize the relevant information. We will

6Continuous support for women during childbirth (Review)

consider it reasonable to combine the results from both if there is little heterogeneity between the study designs and the interaction between the effect of intervention and the choice of randomiza- tion unit is considered to be unlikely. We will also acknowledge heterogeneity in the randomization unit and perform a separate meta-analysis.

Dealing with missing data

For included studies, we noted levels of attrition. We included data for a given outcome which occurred prior to hospital discharge only if the data were available for at least 80% of those originally randomized. For outcomes collected post-hospital discharge we included data if the response rate was higher than 75% and there was no obvious imbalance in groups. For all outcomes we have carried out analyses, as far as possible, on an intention-to-treat basis, i.e. we attempted to include all partici- pants randomized to each group in the analyses. The denominator for each outcome in each trial was the number randomized minus any participants whose outcomes were known to be missing.

Assessment of heterogeneity

We assessed statistical heterogeneity in each meta-analysis using the T2, I² and Chi² statistics. We regarded heterogeneity as sub- stantial if T2 was greater than zero and either I2 was greater than 30% or there was a low P value (less than 0.10) in the Chi² test for heterogeneity. In such cases we took the following steps: 1. a sensitivity analysis, in which methodological weak trials were removed from the analyses and results compared for the primary outcomes; 2. visual inspection of the forest plots for evidence of inconsistency in results; and 3. comparison of the results of fixed-effect and random-effects analyses.

Assessment of reporting biases

Had we suspected reporting bias, we would have attempted to contact study authors asking them to provide missing outcome data. If this were not possible, and the missing data were thought to introduce serious bias, we would not have included the outcome data from that trial.

Data synthesis

We carried out statistical analysis using the Review Manager soft- ware (RevMan 2008). We used fixed-effect Mantel-Haenszel meta- analysis for combining data. We defined heterogeneity as substan- tial if a given meta-analysis resulted in an I2 value greater than 30%, and there was inconsistency among trials in the direction or magnitude of effects (judged visually in the forest plot), or a low (less than 0.10) P value in the Chi2 test for heterogeneity.

We excluded from analyses data for any outcome in which data were missing for more than 20% of those originally randomized.

Subgroup analysis and investigation of heterogeneity

We planned the following subgroup analyses.

A) Three subgroup analyses that concern characteristics of

the childbirth environment

(1) Trials in settings in which women were permitted to be ac- companied by one or more support persons of their own choosing compared with trials in which accompaniment was not permitted; (2) trials conducted in settings in which epidural analgesia was available compared with trials in settings in which it was unavail- able; (3) trials in which there was a policy of routine electronic fetal heart rate monitoring compared with trials in settings in which continuous electronic fetal monitoring was not routine.

(B) One subgroup analysis that concerns characteristics of

the providers of labour support

(4) Trials in which the caregivers were employees of the institution, compared with trials in which the caregivers were not employees and were not members of the woman’s social network, compared to trials in which the providers were not employees and were lay people chosen by the participants (e.g. husband/partner, friend, close relative).

timing of onset of continuous support

(5) Trials in which continuous labour support began prior to or during early labour (as defined by trial authors), compared with trials in which continuous support began in active labour. Because few of the trial reports contained all of the information needed for the above subgroup analyses, we contacted the trial au- thors in an attempt to verify the presence/absence of routine elec- tronic fetal monitoring (EFM), the presence/absence of epidural analgesia and timing of onset of continuous support. We excluded some studies included in the primary comparisons from the sub- group analyses concerning the use of EFM because their status regarding EFM use was unknown. For tests of differences between these subgroups, we recalculated the overall analysis by including only the studies in which EFM use was known. The seven primary outcomes and one secondary outcome were used in the subgroup analyses. While normally subgroup analyses are restricted to primary outcomes, we also included the outcome of caesarean delivery, because there is widespread concern about escalating caesarean rates worldwide, and subgroup analyses could be helpful to policy makers in decisions about the provision of continuous labour support. Thus the outcomes in the subgroup

7Continuous support for women during childbirth (Review)

analyses were: any analgesia/anaesthesia, synthetic oxytocin during labour, spontaneous vaginal birth, caesarean birth, postpartum depression, negative ratings of the birth experience, admission to special care nursery, and breastfeeding at 1-2 months postpartum. When I2 levels were high but the amount of heterogeneity in treat- ment effects was low (as happens when there are a large number of big trials and thus the amount of variation due to sampling error is extremely low), we compared the results of random-effects and fixed-effect analyses. In instances in which the conclusions were not materially different in both methods of analysis, we reported the results of fixed-effect, inverse variance meta-analysis, in order to be able to calculate a Chi2 for the purpose of exploring dif- ferences based on pre-specified subgroups. As a consequence the totals in the subgroup analysis tables are sometimes slightly differ- ent from those in the main comparison, since the main compar- isons used the Mantel-Haenszel rather than the inverse variance method.

Sensitivity analysis

We performed sensitivity analyses, for the primary outcomes, in instances in which there was a high risk of bias associated with the quality of included trials.

R E S U L T S

Description of studies

See: Characteristics of included studies; Characteristics of excluded studies; Characteristics of studies awaiting classification. Please see Characteristics of included studies table. While 22 trials met inclusion criteria, one trial (Thomassen 2003) provided no usable outcome data. We do not describe it here, but provide details in the Characteristics of included studies table. All 21 trials (n = 15,061) that provided usable outcome data were conducted in hospitals. The trials were conducted in Australia, Bel- gium, Botswana, Brazil, Canada, Chile, Finland, France, Greece, Guatemala, Mexico, Nigeria, South Africa, Sweden and the United States, under widely disparate hospital conditions, regulations and routines. There was remarkable consistency in the descriptions of continuous support across all trials. In all instances the interven- tion included continuous or nearly continuous presence, at least during active labour. Nineteen of the 21 trials that provided us- able outcome data (all except Cogan 1988 and Dickinson 2002) also included specific mention of comforting touch and words of praise and encouragement. In 11 trials (Breart - Belgium 1992; Breart - France 1992; Campbell 2006; Cogan 1988; Dickinson 2002; Gagnon 1997;

Hemminki 1990a; Hemminki 1990b; Hodnett 1989; Hodnett 2002; McGrath 2008), hospital policy permitted women to be accompanied by their husbands/partners or other family members during labour, while in the other 10 trials, no additional support people were allowed. Epidural analgesia was not routinely avail- able in six trials (Breart - Greece 1992; Hofmeyr 1991; Kashanian 2010; Klaus 1986; Madi 1999; Morhason-Bello 2009). We were unsuccessful in obtaining information about availability of epidu- ral analgesia in one trial (Cogan 1988). Epidural analgesia was routinely available in the other 14 trials. Electronic fetal heart rate monitoring was not routine in seven trials (Bruggemann 2007; Hofmeyr 1991; Kashanian 2010; Klaus 1986; Langer 1998; Madi 1999; Morhason-Bello 2009). In nine trials (Campbell 2006; Dickinson 2002; Gagnon 1997; Hemminki 1990a; Hemminki 1990b; Hodnett 1989; Hodnett 2002; Kennell 1991; McGrath 2008) electronic fetal monitoring was used routinely. We were un- successful in obtaining information about the use of electronic fe- tal monitoring in five trials (Breart - Greece 1992; Breart - Belgium 1992; Breart - France 1992; Cogan 1988; Torres 1999). It was not possible to categorize most of the trials according to the pre-specified subgroups of early versus active labour. In four trials (Cogan 1988; Hodnett 1989; Klaus 1986; Madi 1999), the support began in early labour. In the other 17 trials, the timing of onset of support was much more heterogenous, as were definitions of early and active labour, in instances in which these were defined. Women were in varying phases of labour, from elective induction to active labour. In addition, the persons providing the support intervention varied in their experience, qualifications and relationship to the labour- ing women. In nine trials (Breart - Belgium 1992; Breart - France 1992; Breart - Greece 1992; Dickinson 2002; Gagnon 1997; Hemminki 1990a; Hemminki 1990b; Hodnett 2002; Kashanian 2010), the support was provided by a member of the hospital staff, for example, a midwife, student midwife or nurse. In seven tri- als the providers were not members of the hospital staff and were not part of the woman’s social network; they were women with or without special training, such as doulas or women who had given birth before (Hodnett 1989; Hofmeyr 1991; Kennell 1991; Klaus 1986; McGrath 1999): a childbirth educator (Cogan 1988), or retired nurses (Langer 1998). In five trials they were companions of the woman’s choice from her social network, with or without brief training -- a female relative or friend or the woman’s hus- band/partner (Bruggemann 2007; Campbell 2006; Madi 1999; Morhason-Bello 2009; Torres 1999).

Risk of bias in included studies

The trials were of generally good quality (Figure 1;Figure 2 ), although the risk of selection bias was high in three small trials (Bruggemann 2007; Hodnett 1989; Kashanian 2010).

8Continuous support for women during childbirth (Review)

Figure 1. Methodological quality summary: review authors’ judgements about each methodological quality

item for each included study.

9Continuous support for women during childbirth (Review)

Figure 2. Methodological quality graph: review authors’ judgements about each methodological quality

item presented as percentages across all included studies

Allocation concealment: Hodnett 2002 used a central, com- puterized randomization service accessed by telephone. In 17 trials (Breart - Belgium 1992; Breart - France 1992; Breart - Greece 1992; Campbell 2006; Dickinson 2002; Gagnon 1997; Hemminki 1990a; Hemminki 1990b; Hofmeyr 1991; Kashanian 2010; Kennell 1991; Klaus 1986; Langer 1998; Madi 1999; McGrath 2008; Morhason-Bello 2009; Torres 1999) random- ization was by sealed, opaque envelopes. In Bruggemann 2007 women picked their treatment allocation from an opaque con- tainer. Two trials used methods that were centrally controlled but not concealed (Cogan 1988; Hodnett 1989). One trial (Thomassen 2003) did not describe the method of random as- signment. Performance bias: neither those providing nor receiving care could be blinded to the presence/absence of a person providing contin- uous support. Hodnett 2002 provided evidence to discount con- tamination and co-intervention as serious threats to validity. Attrition bias: we did not include data for outcomes assessed in hospital in a comparison if there was more than 20% loss to follow- up; we did not include longer-term outcome data if there was more than 25% loss to follow-up; based on this criterion, one trial (Thomassen 2003) provided no usable outcome data. Detection bias: in the trials which sought participants’ evalua- tions of their birth experiences (Breart - Belgium 1992; Breart - France 1992; Hofmeyr 1991; Hodnett 2002; Kennell 1991), ef-

forts were made to reduce response bias, through use of an inter- viewer blinded to the woman’s group allocation or self-adminis- tered questionnaires.

Effects of interventions

Main comparison: continuous support versus usual

care - all trials

We considered 17 outcomes. Between one and 21 trials con- tributed to the analyses of each outcome. Sensitivity analyses, con- ducted by removing the trials (all of which were small) with a high likelihood of selection bias (Bruggemann 2007, Hodnett 1989; Kashanian 2010) did not alter the conclusions. According to our pre-specified criteria, there was substantial statistical heterogene- ity in all but four outcomes (instrumental vaginal birth, low 5- minute Apgar score, low postpartum self-esteem and postpartum depression). Inspection of the forest plots did not suggest sources of heterogeneity. Comparisons of fixed-effect and random-effects analyses did not yield substantive differences nor alter conclu- sions. We report results of average random-effects analyses for all comparisons, for all outcomes except instrumental vaginal birth, low 5-minute Apgar score, low postpartum self-esteem data, and postpartum depression. (Each of the latter two comparisons only contain data from one trial.) We have noted in the text the three instances in which fixed-effect analysis was used.

10Continuous support for women during childbirth (Review)

Primary outcomes

Women who had continuous, one-to-one support during labour were: more likely to have

• a spontaneous vaginal birth (18 trials, n = 14,005, RR 1.08, 95% CI 1.04 to 1.12, I2 48%, Ñ‚2 0.00);

less likely to have • any intrapartum analgesia/anaesthesia (13 trials, n =

12,169, RR 0.90, 95% CI 0.84 to 0.97, I2 76%, Ñ‚2 0.01); • reported negative rating of/negative feelings about

childbirth experience (11 trials, n = 11,133, RR 0.69, 95% CI 0.59 to 0.79, I2 63%, Ñ‚2 0.03);

and there was no apparent impact of continuous support on • use of synthetic oxytocin during labour (14 trials, n =

12,506; RR 0.97, 95% CI 0.90 to 1.04, I2 67%, Ñ‚2 0.01); • admission to the special care nursery (7 trials; n = 8897; RR

0.97, 95% CI 0.76 to 1.25, I2 37%, Ñ‚2 0.03); • breastfeeding at 1-2 months postpartum (3 trials, n = 5363,

RR 1.01, 95% CI 0.94 to 1.09, I2 52%, Ñ‚2 0.00); and

• postpartum depression (1 trial, n = 5567; RR = 0.86, 95% CI 0.73 to 1.02, fixed-effect).

Secondary outcomes

Women who had continuous, one-to-one support were: more likely to have

• shorter labours (11 trials; n = 5269; mean difference -0.58 hours, 95% CI -0.86 to -0.30, I2 50%, Ñ‚2 0.09);

less likely to have • regional analgesia/anaesthesia (9 trials; n = 11,444, RR

0.93, 95% CI 0.88 to 0.99, I2 81%, Ñ‚2 0.01); • an instrumental vaginal birth (18 trials; n = 14,004; RR

0.90, 95% CI 0.84 to 0.96, fixed-effect); • a caesarean birth (21 trials; n = 15,061; RR 0.79, 95% CI

0.67 to 0.92, I2 55%, Ñ‚2 0.05); • a baby with a low 5-minute Apgar score (12 trials; n =

12,401; RR 0.70, 95% CI 0.50 to 0.96, fixed-effect);

and there was no apparent impact of continuous labour support on

• the likelihood of serious perineal trauma (4 trials; n = 8120; RR 0.97, 95% CI 0.92 to 1.01, I2 44%, Ñ‚2 0.00);

• severe labour pain (4 trials; n = 2456; RR 1.00, 95% CI 0.83 to 1.12, I2 78%, Ñ‚2 0.03);

• difficulty mothering (3 trials; n = 6308, RR 0.60, 95% CI 0.35 to 1.02, I2 94%, Ñ‚2 0.19);

• low postpartum self-esteem (1 trial; n = 652; RR 1.00, 95% CI 0.77 to 1.30, fixed-effect); and

• prolonged neonatal hospital stay (3 trials; n = 1098, RR 0.83, 95% CI 0.42 to 1.65, I2 62%, Ñ‚2 0.15).

Subgroup comparisons

For the first time, the Review includes trials of support by compan- ions of the woman’s own choosing, i.e. husband/partner, relative, or friend from her existing social network. Therefore we grouped the trials according to the following provider characteristics: 1) staff members of the hospital; 2) neither hospital employees nor part of the woman’s social network; and 3) chosen by the woman from her social network. We have presented the results of the subgroup analyses below. While we made every effort to obtain the required information from trial authors, none of the subgroup comparisons are based on the total number of included trials for which usable data were available. Thus results must be interpreted with caution. The text below does not present the results for postpartum depression or breastfeeding at 1-2 months postpartum, because too few trials provided data. Only one trial contributed data about postpar- tum depression (Hodnett 2002) and three about breastfeeding (Hodnett 2002; Hofmeyr 1991; Langer 1998). We were unable to conduct the planned subgroup comparison based on timing of onset of labour support. It was not possible to categorize most of the trials according to the pre-specified sub- groups of early versus active labour. In four trials (Cogan 1988; Hodnett 1989; Klaus 1986; Madi 1999), the support began in early labour. In the other 17 trials, the timing of onset of support was much more heterogenous, as were definitions of early and active labour, in instances in which these were defined. Women were in varying phases of labour, from elective induction to active labour. As noted in Subgroup analysis and investigation of heterogeneity, totals in the subgroup analysis figures may differ slightly from those in the main comparisons, because a different method of analysis had to be used. All subgroup comparisons used fixed-effect, to allow computation of tests for differences between subgroups.

Outcome: any intrapartum analgesia/anaesthesia

1. Policies about the presence of companions during labour and birth: In seven trials (n = 9752) companions were permitted; RR 0.97, 95% CI 0.96 to 0.99, while in six trials (n = 2484) companions were not permitted; RR 0.91, 95% CI 0.85 to 0.96. Chi2 for the subgroup comparison = 4.98, P = 0.03.

2. Availability of epidural analgesia: In nine trials (n = 10,888), epidural analgesia was routinely available; RR 0.97, 95% CI 0.96 to 0.98. In four trials (n = 1348) epidural analgesia was not routinely available; RR 0.83, 95% CI 0.69 to 0.99. Chi2

for the subgroup comparison = 2.89, P = 0.09. 3. Routine use of EFM: in six trials (n = 8580), EFM was

routine; RR 0.97, 95% CI 0.96 to 0.99. In five trials (n = 2072), EFM was not routine; RR 0.96, 95% CI 0.90 to 1.03. In two trials (n = 1579), the policy about routine EFM was unknown; RR 0.89, 95% CI 0.80 to 0.99. Chi2 for the subgroup comparison = 2.31, P = 0.32.

11Continuous support for women during childbirth (Review)

4. Provider characteristics: in six trials (n = 9152) the support was provided by a member of the hospital staff; RR 0.97, 95% CI 0.95 to 0.98. In four trials (n = 1790), the support was provided by a woman who was not a member of the staff and was not part of the woman’s social network; RR 0.91, 95% CI 0.86 to 0.97. In three trials (n = 1294) the support was provided by a member of the woman’s social network; RR 0.94, 95% CI 0.88 to 1.00. Chi2for the subgroup comparison = 4.76, P = 0.09. Thus, the effects of continuous support on use of any intrapartum analgesia/anaesthesia appeared to be stronger in settings where companions were not permitted, but did not appear to be influ- enced by the availability of epidural analgesia, the use of routine EFM, or provider characteristics.

Outcome: synthetic oxytocin during labour

1. Policies about the presence of companions: in five trials (n = 9495) companions were permitted; RR 1.04, 95% CI 0.99 to 1.10. In nine trials (n = 3011) companions were not permitted; RR 0.99, 95% CI 0.97 to 1.01. Chi2for the subgroup comparison = 3.16, P = 0.08.

2. Availability of epidural analgesia: in eight trials (n = 10,568) epidural analgesia was routinely available; RR 1.00, 95% CI 0.98 to 1.02. In six trials (n = 1952), epidural analgesia was not routinely available; RR 1.02, 95% CI 0.93 to 1.11. Chi2for the subgroup comparison = 0.17, P = 0.68.

3. Use of routine EFM: in four trials (n = 8340) EFM was routine; RR 1.04, 95% CI 0.98 to 1.11. In six trials (n = 1612) EFM was not routine; RR 0.99, 95% CI 0.96 to 1.01. In 4 trials (n = 2568) it is not known whether EFM was routine; RR 1.02, 95% CI 0.97 to 1.08. Chi2 for the subgroup comparison = 3.32, P = 0.19.

4. Provider characteristics: in six trials (n = 9561), the support was provided by a member of the hospital staff; RR 1.06, 95% CI 1.01 to 1.11. In three trials (n = 1018), the support was provided by a woman who was not a member of the staff and was not part of the woman’s social network; RR 0.69, 95% CI 0.50 to 0.94. In five trials (n = 1927), the support was provided by a member of the woman’s social network; RR 0.99, 95% CI 0.96 to 1.01. Chi2for the subgroup comparison = 11.51, P = 0.003. Thus the effects of continuous support on use of synthetic oxytocin during labour did not appear to be influenced by policies about the presence of companions, use of routine EFM, or availability of epidural analgesia. The effectiveness of continuous support in reducing the likelihood of intrapartum oxytocin seemed to be strongest when the provider was neither a staff member nor part of the woman’s social network.

Outcome: spontaneous vaginal birth

1. Policies about companions: In nine trials (n = 10,889) companions were permitted; RR 1.03, 95% CI 1.00 to 1.05. In

nine trials (n = 3215) companions were not permitted; RR1.12, 95% CI 1.07 to 1.16. Chi2 for the subgroup comparison = 12.04, P = 0.005.

2. Availability of epidural analgesia: In 13 trials (n = 12,672), epidural analgesia was routinely available; RR 1.04, 95% CI 1.01 to 1.06). In five trials (n = 1432) epidural analgesia was not routinely available; RR 1.12, 95% CI 1.06 to 1.17. Chi2 for the subgroup comparison = 6.82, P = 0.009.

3. Routine use of EFM: In eight trials (n = 9717) EFM was routine; RR 1.03, 95% CI 1.01 to 1.06. In six trials (n = 1799) EFM was not routine; RR 1.12, 95% CI 1.06 to 1.17. In 4 trials (n = 2561), the policy about routine EFM is not known; RR 1.07, 95% CI 1.01 to 1.13. Chi2 for the subgroup comparison = 8.78, P = 0.01.

4. Provider characteristics: in nine trials (n = 10,813) the support was provided by a member of the hospital staff; RR 1.03, 95% CI 1.01 to 1.06. In five trials (n = 1935) the support was provided by a woman who was not part of the hospital staff nor part of the woman’s social network; RR 1.12, 95% CI 1.07 to 1.17. In four trials (n = 1356), the support was provided by a member of the woman’s social network; RR 1.07, 95% CI 0.99 to 1.15. Chi2 for the subgroup comparison = 10.00, P = 0.007. Thus the effectiveness of continuous support in increasing the likelihood of spontaneous vaginal birth appeared to be stronger when hospital policies did not permit companions, when epidural analgesia was not available, when EFM was not routine, and when the support provider was neither a staff member nor part of the woman’s social network.

Outcome: caesarean birth

1. Policies about companions: in 11 trials (n = 11,326) companions were permitted; RR 0.94, 95% CI 0.85 to 1.03. In 10 trials (n = 3735) companions were not permitted; RR 0.75, 95% CI 0.65 to 0.87. Chi2 for the subgroup comparison = 6.10, P = 0.01.

2. Availability of epidural analgesia: in 14 trials (n = 13,064), epidural analgesia was routinely available; RR 0.93, 95% CI 0.86 to 1.02. In six trials (n = 1963), epidural analgesia was not routinely available; RR 0.52, 95% CI 0.41 to 0.67. In one very small trial (n = 34), we were unable to determine if epidural analgesia was routinely available; RR 1.40, 95% CI 0.14 to 13.98. Chi2 for the subgroup comparison = 19.40, P < 0.0001.

3. Routine use of EFM: in nine trials (n = 10,123), EFM was routine; RR 0.92, 95% CI 0.83 to 1.01. In seven trials (n = 2343) EFM was not routine; RR 0.66, 95% CI 0.55 to 0.80. In five trials (n = 2595), it is not known whether EFM was routine; RR 1.06, 95% CI 0.84 to 1.33. Chi2 for the subgroup comparison = 12.38, P = 0.002.

4. Provider characteristics: in nine trials (n = 10,786), the support was provided by a member of the hospital staff; RR 0.95, 95% CI 0.85 to1.05. In seven trials (n = 2330), the support was

12Continuous support for women during childbirth (Review)

provided by a woman who was not a member of the hospital staff and not part of the woman’s social network; RR 0.72, 95% CI 0.60 to 0.86. In five trials (n = 1945), the support was provided by a member of the woman’s social network; RR 0.84, 95% CI 0.69 to 1.03. Chi2 for the subgroup comparison = 6.75, P = 0.03. Thus the effectiveness of continuous support in reducing the like- lihood of caesarean birth appeared to be stronger in settings where companions were not permitted, epidural analgesia was not rou- tinely available and EFM was not routine, and when the provider was neither a staff member nor part of the woman’s social network.

Outcome: admission to special care nursery

1. Policies about companions: in two trials (n = 7328), companions were permitted; RR 0.99, 95% CI 0.84 to 1.17. In five trials (n = 1569), companions were not permitted; RR 0.91, 95% CI 0.71 to 1.17. Chi2 for the subgroup comparison = 0.28, P = 0.60.

2. Availability of epidural analgesia: in five trials (n = 8380) epidural analgesia was routinely available; RR 0.98, 95% CI 0.85 to 1.13. In two trials (n = 517) epidural analgesia was not routinely available; RR 0.26, 95% CI 0.08 to 0.88. Chi2 for the subgroup comparison = 4.51, P = 0.03.

3. Routine use of EFM: in three trials (n = 7740) EFM was routine; RR 0.97, 95% CI 0.84 to 1.11. In three trials (n = 729) EFM was not routine; RR 0.48, 95% CI 0.21 to 1.12. In one trial (n = 428), it is not known whether EFM was routine; RR 1.98, 95% CI 0.76 to 5.18. Chi2 for the subgroup comparison = 4.76, P = 0.09.

4. Provider characteristics: in three trials (n = 7428), the support was provided by a member of the hospital staff; RR 0.99, 95% CI 0.84, 1.17. In two trials (n = 829), the support was provided by a woman who was not a member of the hospital staff and not part of the woman’s social network; RR 0.86, 95% CI 0.66 to 1.12. In two trials (n = 640) the support was provided by a member of the woman’s social network; RR 1.40, 95% CI 0.67 to 2.93. Chi2 for the subgroup comparison = 1.74, P = 0.42. Thus the effectiveness of continuous support in reducing the like- lihood of admission of the newborn to a special care nursery ap- peared to be stronger in settings in which epidural analgesia was not routinely available, but effectiveness did not appear to be in- fluenced by policies about companions or routine EFM, or by provider characteristics.

Outcome: negatives ratings of/negative views about the

birth experience

1. Policies about companions: in five trials (n = 8639) companions were permitted; RR 0.70, 95% CI 0.62 to 0.78. In six trials (n = 2539) companions were not permitted; RR 0.62, 95%CI 0.56 to 0.69. Chi2 for the subgroup comparison = 2.03, P = 0.15.

2. Availability of epidural analgesia: in nine trials (n = 10,404) epidural analgesia was routinely available; RR 0.70, 95% CI 0.64 to 0.77. In two trials (n = 774) epidural analgesia was not routinely available; RR 0.55, 95% CI 0.48 to 0.63. Chi2 for the subgroup comparison = 7.92, P 0.0005.

3. Routine use of EFM: four trials (n = 7467) were conducted in settings with routine EFM; RR 0.67, 95% CI 0.60 to 0.76. Four trials (n = 1710) were conducted in settings in which EFM was not routine; RR 0.60, 95% CI 0.53 to 0.68. Three trials (n = 1977) were in settings in which the use of routine EFM is not known; RR 0.84, 95% CI 0.65 to 1.08. Chi2 for the subgroup comparison = 5.55, P = 0.06.

4. Provider characteristics: in four trials (n = 8145) support providers were hospital staff; RR 0.87, 95% CI 0.73 to 1.03. In three trials (n = 1325) the providers were not hospital staff and not part of the woman’s social network; RR 0.66, 95% CI 0.57 to 0.77. In four trials (n = 1708), providers were part of the woman’s social network; RR 0.57, 95% CI 0.51 to 0.64. Chi2

for the subgroup comparison = 16.47, P = 0.0003. Thus the effectiveness of continuous support in reducing the like- lihood of dissatisfaction with or negative views of the childbirth experience appeared to be stronger in settings in which epidural analgesia was not routinely available, and when the provider was neither a staff member nor part of the woman’s social network.

D I S C U S S I O N

This Review summarizes results of 21 trials involving 15,061 women, conducted in 15 countries under a wide variety of circum- stances. Continuous one-to-one support was given by providers with a variety of experiences, through having given birth them- selves and/or through education and practice as nurses, midwives, doulas or childbirth educators, or by the woman’s husband or part- ner, female relative or close friend. The methodological quality of the trials was generally good to excellent. Much of the heterogene- ity in the trials appears to be due to wide variations in the size of the trials; comparisons of fixed-effect and random-effects analyses did not yield material differences in the results. Thus neither the risk of bias nor heterogeneity should be of concern when inter- preting results.

In the primary comparison, women who were allocated to contin- uous one-to-one support were more likely to have a spontaneous vaginal birth (RR 1.08, 95% CI 1.04 to 1.12) and less likely to have intrapartum analgesia (RR 0.90, 95% CI 0.84 to 0.97) or to report dissatisfaction (RR 0.69, 95% CI 0.59 to 0.79). In ad- dition their labours were shorter (mean difference -0.58 hours, 95% CI -0.86 to -0.30), they were less likely to have a caesarean (RR 0.79, 95% CI 0.67 to 0.92) or instrumental vaginal birth (RR 0.90, 95% CI 0.84 to 0.96), regional analgesia (RR 0.93, 95% CI 0.88 to 0.99), or a baby with a low five-minute Apgar

13Continuous support for women during childbirth (Review)

score (RR 0.70, 95% CI 0.50 to 0.96). The trial reports do not list any adverse effects. This form of care appears to confer impor- tant benefits without attendant risks. The results of earlier versions of this Review prompted organizations in Canada, the UK and the USA to issue practice guidelines, advocating continuous sup- port (AWHONN 2002; NICE Intrapartum Care 2007; MIDIRS 1999; SOGC 1995). The results of the primary comparison in the current Review offer continued justification for such practice guidelines.

The subgroup analyses should be interpreted with caution. Indi- vidually each should be considered exploratory and hypothesis- generating, particularly when the sample size in one subgroup was much smaller than in another. However, taken in their totality, the consistency of the patterns suggests that the effectiveness of continuous intrapartum support may be enhanced or reduced by policies and practices in the birth setting and by the nature of the relationship between the provider and labouring woman.

We chose three aspects of the birth environment - routine use of electronic fetal monitoring, availability of epidural analgesia and policies about the presence of additional support people of the woman’s own choosing - as proxies for environmental conditions that may mediate the effectiveness of labour support. This Review cannot answer questions about the mechanisms whereby settings with epidural analgesia limit the effectiveness of labour support. The impact of epidural analgesia may be direct (Anim-Somuah 2005) or indirect, as part of the ’cascade of interventions’ described in the Background. The effects of a policy of routine EFM are less clear, most likely because we were unable to obtain information about EFM policies for several of the trials. However continuous labour support in settings without routine EFM was associated with greater likelihood of spontaneous vaginal birth and lower likelihood of a caesarean birth. These results raise questions about the ability of labour support to act as a buffer against adverse as- pects of routine medical interventions. Labour support appears to be effective in reducing the adverse consequences of the fear and distress associated with labouring alone in an unfamiliar environ- ment. A report of a qualitative component of one of the included trials (Langer 1998), aptly titled “Alone, I wouldn’t have known what to do”, provides further justification for this argument.

Effects of continuous labour support appear to vary by provider characteristics. Divided loyalties, additional duties besides labour support, self-selection and the constraints of institutional policies and routine practices may all have played a role in the apparently limited effectiveness of members of the hospital staff. Childbirth environments influence the healthcare professionals who work in them as well as labouring women and their support people. Fur- thermore, while women want and benefit from the presence of selected members of their social network, the support of partners and others with whom they have a longstanding relationship is qualitatively different and more complex than that of a woman who is experienced and often trained to provide labour support

and who has no other role other than to provide it. An early trial of labour support with partners present found that women received more support from their partners when a doula was present to guide them, and the partners themselves reported more support (Hodnett 1989). While continuous labour support appears to be more effective when it is provided by caregivers who are not em- ployees of an institution (and thus have no obligation to anyone other than the labouring woman) and who have an exclusive focus on this task, the trials of husband/partner/relative/friend support in this update to the Review demonstrate that support from a member of the woman’s social network is also effective in improv- ing women’s satisfaction with their birth experiences.

There remains relatively little information about the effects of continuous intrapartum support on mothers’ and babies’ health and well-being in the postpartum period.

A U T H O R S ’ C O N C L U S I O N S

Implications for practice

Continuous support during labour should be the norm, rather than the exception. Hospitals should permit and encourage women to have a companion of their choice during labour and birth, and hospitals should implement programs to offer contin- uous support during labour. Policy makers and hospital adminis- trators in high-income countries who wish to effect clinically im- portant reductions in inappropriately high caesarean rates should be cautioned that continuous support by nurses or midwives may not achieve this goal, in the absence of other changes to policies and routines. In many settings, the labour ward functions accord- ing to a risk-oriented, technology-dominated approach to care. Institutional staff are unlikely to be able to offer labouring women benefits comparable to non-staff members, in the absence of fun- damental changes in the organization and delivery of maternity care. Changes to the content of health professionals’ education and to the core identity of professionals may also be important. Policy makers and administrators must look at system reform and rigorous attention to evidence-based use of interventions that were originally developed to diagnose or treat problems and are now used routinely during normal labours. Given the clear benefits and absence of adverse effects of continuous labour support, policy makers should consider including it as a covered service for all women.

Every effort should be made to ensure that women’s birth envi- ronments are empowering, non-stressful, afford privacy, commu- nicate respect and are not characterized by routine interventions that add risk without clear benefit. In most areas of the world, childbearing women have limited or no access to trained doulas. Where available, costs of doula services are frequently borne by childbearing families and may be a barrier to access. In areas where doulas are not available, a comprehensive guidebook for desig-

14Continuous support for women during childbirth (Review)

nated companions is available for those with good English liter- acy (Simkin 2007). The ’Better Births Initiative’ is a structured motivational program which promotes humane, evidence-based care during labour. The program focuses on promoting labour companionship and avoiding unproven interventions such as rou- tine starvation, supine position and routine episiotomy. The ed- ucational materials for the Better Births Initiative include a video presentation on childbirth companions which is available in the World Health Organization Reproductive Health Library (WHO 2010). It can be accessed free of charge on the internet in Arabic, Chinese, French, English, Spanish, Russian and Vietnamese and is distributed on CD to health workers in resource-poor countries. The selection of Cochrane Reviews in the Reproductive Health Library includes this Review of continuous labour support.

Implications for research

There remains relatively little information about the effects of continuous intrapartum support on mothers’ and babies’ health and well-being in the postpartum period, and thus trials across all types of settings, which include a focus on longer-term outcomes for mother and baby, would be helpful. The trials in resource- constrained countries were relatively small, and additional, large trials may be required in such settings, where the cost of provid- ing continuous support may compete with other resource prior- ities. Particular attention should be paid to outcomes that have

been under-researched in resource-poor settings, but are causes of significant morbidity, including urinary and faecal incontinence, pain during intercourse, prolonged perineal pain and depression.

Trials of different models of training providers of labour support would help to inform decision makers about the most effective models in the context of their settings. All trials should include economic analyses of the relative costs and benefits.

A C K N O W L E D G E M E N T S

We are very grateful to the investigators who provided additional information: O Bruggemann, D Campbell, R Cogan, A Gagnon, E Hemminki, M Kashanian, J Kennell, M Klaus, A Langer, B Madi, S McGrath, G Trueba and E Kopplin. We thank Agnes Cho, Qian Xu and Jiang Huangye for translation of Chinese publica- tions, and Qian Xu for contacting the trial author for additional details. Ellen Hodnett and Justus Hofmeyr also provided addi- tional information about their trials. Tanya Webb performed the second data entry on the earlier version of the Review, contacted trial authors for additional information and provided secretarial support. The Consumer Panel of the Pregnancy and Childbirth Group (of which Carol Sakala is a member) provided many help- ful suggestions for both the Protocol and earlier versions of the Review.

R E F E R E N C E S

References to studies included in this review

Breart - Belgium 1992 {published data only} ∗ Breart G, Garel M, Mlika-Cabanne N. Evaluation of different policies of management of labour for primiparous women. Trial B: Results of the continuous professional support trial. In: Kaminski M editor(s). Evaluation in pre-, peri-, and post-natal care delivery

systems. Paris: INSERM, 1992:57–68. Breart G, Mlika-Cabane N, Kaminski M. The evaluation of different policies for the management of labour. Proceedings of 3rd European Health Services Research Meeting; 1991 Dec 13-14; London, UK. 1991. Breart G, Mlika-Cabane N, Kaminski M, Alexander S, Herruzo- Nalda A, Mandruzzato P, et al.Evaluation of different policies for the management of labour. Early Human Development 1992;29: 309–12. Breart G, Mlika-Cabane N, Thornton J, Trakas D, Alexander S, Mandruzzato P, et al.European trials on artificial rupture of membranes and professional support during labour. Journal of

Perinatal Medicine 1992;20(Suppl 1):37.

Breart - France 1992 {published data only} ∗ Breart G, Garel M, Mlika-Cabanne N. Evaluation of different policies of management of labour for primiparous women. Trial B: Results of the continuous professional support trial. In: Kaminski

M editor(s). Evaluation in pre-, peri-, and post-natal care delivery

systems. Paris: INSERM, 1992:57–68. Breart G, Mlika-Cabane N, Kaminski M. The evaluation of different policies for the management of labour. Proceedings of 3rd European Health Services Research Meeting; 1991 Dec 13-14; London, UK. 1991. Breart G, Mlika-Cabane N, Kaminski M, Alexander S, Herruzo- Nalda A, Mandruzzato P, et al.Evaluation of different policies for the management of labour. Early Human Development 1992;29: 309–12. Breart G, Mlika-Cabane N, Thornton J, Trakas D, Alexander S, et al.European trials on artificial rupture of membranes and professional support during labour. Journal of Perinatal Medicine

1992;20(Suppl 1):37.

Breart - Greece 1992 {published data only} ∗ Breart G, Garel M, Mlika-Cabanne N. Evaluation of different policies of management of labour for primiparous women. Trial B: Results of the continuous professional support trial. In: Kaminski M editor(s). Evaluation in pre-, peri-, and post-natal care delivery

15Continuous support for women during childbirth (Review)

London, UK. 1991. Breart G, Mlika-Cabane N, Kaminski M, Alexander S, Herruzo- Nalda A, Mandruzzato P, et al.Evaluation of different policies for the management of labour. Early Human Development 1992;29: 309–12. Breart G, Mlika-Cabane N, Thornton J, Trakas D, Alexander S, et al.European trials on artificial rupture of membranes and professional support during labour. Journal of Perinatal Medicine

1992;20(Suppl 1):37.

Bruggemann 2007 {published and unpublished data}

Bruggemann OM, Parpinelli MA, Osis MJD, Cecatti JG, Neto ASC. Support to woman by a companion of her choice during childbirth: a randomized controlled trial. Reproductive Health

2007;4:5.

Campbell 2006 {published and unpublished data}

Campbell D, Scott KD, Klaus MH, Falk M. Female relatives or friends trained as labor doulas: outcomes at 6 to 8 weeks postpartum. Birth 2007;34(3):220–7. ∗ Campbell DA, Lake MF, Falk M, Backstrand JR. A randomized control trial of continuous support in labor by a lay doula. Journal

of Obstetric, Gynecologic, and Neonatal Nursing 2006;35(4):456–64.

Cogan 1988 {published and unpublished data}

Cogan R, Spinnato JA. Social support during premature labor: effects on labor and the newborn. Journal of Psychosomatic Obstetrics

and Gynaecology 1988;8:209–16.

Dickinson 2002 {published and unpublished data}

Dickinson JE, Paech MJ, McDonald SJ, Evans SF. Maternal satisfaction with childbirth and intrapartum analgesia in nulliparous labour. Australian and New Zealand Journal of Obstetrics

and Gynaecology 2003;43:463–8. ∗ Dickinson JE, Paech MJ, McDonald SJ, Evans SF. The impact of intrapartum analgesia on labour and delivery outcomes in nulliparous women. Australian and New Zealand Journal of

Obstetrics and Gynaecology 2002;42(1):59–66. Henderson JJ, Dickinson JE, Evans SF, McDonald SJ, Paech MJ. Impact of intrapartum epidural analgesia on breast-feeding duration. Australian and New Zealand Journal of Obstetrics and

Gynaecology 2003;43:372–7.

Gagnon 1997 {published and unpublished data}

Gagnon A, Waghorn K. One-to-one nurse labor support of nulliparous women stimulated with oxytocin. Journal of Obstetric,

Gynecologic and Neonatal Nursing 1999;28:371–6. ∗ Gagnon A, Waghorn K, Covell C. A randomized trial of one-to- one nurse support of women in labor. Birth 1997;24:71–7.

Hemminki 1990a {published data only}

Hemminki E, Virta AL, Koponen P, Malin M, Kojo-Austin H, Tuimala R. A trial on continuous human support during labor: feasibility, interventions and mothers’ satisfaction. (Trial A - Pilot study with volunteered midwifery students). Journal of

Psychosomatic Obstetrics and Gynaecology 1990;11:239–50.

Hemminki 1990b {published data only}

Psychosomatic Obstetrics and Gynaecology 1990;11:239–50.

Hodnett 1989 {published and unpublished data}

Hodnett ED, Osborn RW. A randomized trial of the effects of monitrice support during labor: mothers’ views two to four weeks postpartum. Birth 1989;16:177–83. ∗ Hodnett ED, Osborn RW. Effects of continuous intrapartum professional support on childbirth outcomes. Research in Nursing

and Health 1989;12:289–97.

Hodnett 2002 {published and unpublished data} ∗ Hodnett ED, Lowe NK, Hannah ME, Willan AR, Stevens B, Weston JA, et al.Effectiveness of nurses as providers of birth labor support in North American hospitals. A randomized controlled trial. JAMA 2002;288(11):1373–81. Muir HA, Hodnett ED, Hannah ME, Lowe NK, Willan AR, Stevens B, et al.The influence of continuous labor support on the choice of analgesia, ambulation and obstetric outcome [abstract]. Anesthesiology 2002;96(Suppl 1):P44.

Hofmeyr 1991 {published and unpublished data}

Chalmers B, Wolman WL, Hofmeyr GJ, Nikodem C. Companionship in labour: effect on the mother-infant relationship. Proceedings of the International Conference on Primary Care Obstetrics and Perinatal Health; 1991; Utrecht, The Netherlands. 1991:50. Chalmers B, Wolman WL, Hofmeyr GJ, Nikodem C. Companionship in labour and the mother-infant relationship: preliminary report of a randomised trial. Proceedings of the 9th Conference on Priorities in Perinatal Care; 1990 March; Johannesburg, South Africa. 1990:139–41. Gulmezoglu AM, Chalmers BE, Nikodem VC, Wolman WL, Hofmeyr GJ. Companionship in labour: do the personality characteristics of labour supporters influence effectiveness?. Proceedings of the 11th Conference on Priorities in Perinatal Care in South Africa; 1992 March; Caledon, South Africa. 1992:115–6. Hofmeyr GJ, Nikodem C, Gulmezoglu M, Wolman WL. Companionship to modify the clinical birth environment: long- term effects on mother and child. Proceedings of the 11th Conference on Priorities in Perinatal Care in South Africa; 1992 March; Caledon, South Africa. 1992:113–4. Hofmeyr GJ, Nikodem C, Gulmezoglu M, Wolman WL. Companionship to modify the clinical birth environment: long- term effects on mother and child. Proceedings of the 26th British Congress of Obstetrics and Gynaecology; 1992 July 7-10; Manchester, UK. 1992:34. Hofmeyr GJ, Nikodem VC, Chalmers BE, Kramer T. Clinically orientated care during labour reduces the chance of successful breastfeeding. Proceedings of the 10th Conference on Priorities in Perinatal Care in South Africa; 1991 March 12-15; Eastern Transvaal, South Africa. 1991:107–9. Hofmeyr GJ, Nikodem VC, Mahomed K, Gulmezoglu AM, et al.Companionship to modify the clinical birth environment: no measurable effect on stress hormone levels. Journal of Obstetrics and

Gynaecology 1995;15:178–81. ∗ Hofmeyr GJ, Nikodem VC, Wolman WL, Chalmers BE, Kramer T. Companionship to modify the clinical birth environment: effects on progress and perceptions of labour, and breastfeeding. British Journal of Obstetrics and Gynaecology 1991;98:756–64. Nikodem VC, Nolte AG, Wolman W, Gulmezoglu AM, Hofmeyr GJ. Companionship by a lay labour supporter to modify the clinical

16Continuous support for women during childbirth (Review)

birth environment: long-term effects on mother and child. Curationis 1998;21(1):8–12. Trotter C, Wolman WL, Hofmeyr J, Nikodem C, Turton R. The effect of social support during labour on postpartum depression. South African Journal of Psychology 1992;22(3):134–9. Wolman WL, Chalmers B, Hofmeyr J, Nikodem VC. Postpartum depression and companionship in the clinical birth environment: a randomized, controlled study. American Journal of Obstetrics and

Gynecology 1993;168:1388–93.

Kashanian 2010 {published data only}

Kashanian M, Javadi F, Haghighi MM. Effect of continuous support during labor on duration of labor and rate of cesarean delivery. International Journal of Gynecology & Obstetrics 2010;109

(3):198–200.

Kennell 1991 {published and unpublished data} ∗ Kennell J, Klaus M, McGrath S, Robertson S, Hinkley C. Continuous emotional support during labor in a US hospital. JAMA 1991;265:2197–201. Kennell J, Klaus M, McGrath S, Robertson S, Hinkley C. Medical intervention: the effect of social support during labour. Proceedings of Annual Meeting of the American Pediatric Society/ Society for Pediatric Research; 1988 May; USA. 1988. Kennell J, McGrath S, Klaus M, Robertson S, Hinkley C. Labor support: what’s good for the mother is good for the baby. Pediatric

Research 1989;25:15A. Martin S, Landry S, Stellman L, Kennell J, McGrath S. The effect of doula support during labor on mother-infant interaction at 2 months. Infant Behaviour and Development 1998;21 Supp1:556.

Klaus 1986 {published and unpublished data}

Klaus MH, Kennell JH, Robertson SS, Sosa R. Effects of social support during parturition on maternal and infant morbidity. BMJ

1986;293:585–7.

Langer 1998 {published and unpublished data}

Campero L, Garcia C, Diaz C, Ortiz O, Reynoso S, Langer A. “Alone, I wouldn’t have known what to do”: a qualitative study on social support during labor and delivery in Mexico. Social Science

and Medicine 1998;47:395–403. ∗ Langer A, Campero L, Garcia C, Reynoso S. Effects of psychosocial support during labour and childbirth on breastfeeding, medical interventions, and mothers’ wellbeing in a Mexican public hospital: a randomised clinical trial. British Journal of Obstetrics and

Gynaecology 1998;105:1056–63.

Madi 1999 {published and unpublished data}

Madi BC, Sandall J, Bennett R, MacLeod C. Effects of female relative support in labor: a randomized controlled trial. Birth 1999; 26:4–8.

McGrath 2008 {published data only}

McGrath SK, Kennell JH. A randomized controlled trial of continuous labor support for middle-class couples: effect on cesarean delivery rates. Birth 2008;35(2):92–7.

Morhason-Bello 2009 {published data only} ∗ Morhason-Bello IO, Adedokun BO, Ojengbede OA, Olayemi O, Oladokun A, Fabamwo AO. Assessment of the effect of psychosocial support during childbirth in Ibadan, south-west

Nigeria: a randomised controlled trial. Australian and New Zealand

Journal of Obstetrics and Gynaecology 2009;49(2):145–50. Ojengbede O, Morhason-Bello I, Adedokun B, Becker S, Oni G, Tsui A. Psycho-social support in labour, as a catalyst for contraceptive uptake in Nigeria: preliminary analysis of a randomised controlled trial. International Journal of Gynecology &

Obstetrics 2009;107(Suppl 2):S623–S624.

Thomassen 2003 {published data only}

Thomassen P, Lundwall M, Wiger E, Wollin L, Uvnas-Moberg K. Lakartidningen. Doula--a new concept in obstetrics [Doula—-ett nytt begrepp inom forlossningsvarden]. Lakartidningen 2003;100

(51-52):4268–71.

Torres 1999 {published data only}

Kopplin E, Torres-Pereyra J, Peña V, Salinas R. Impact of psychosocial supports during childbirth: the decrease of caesarean and bonuses of the process. Pediatric Research 2000;47:834. ∗ Torres J, Kopplin E, Pena V, Klaus M, Salinas R, Herrera M. Impact of emotional support during labour in the decrease of caesarean sections and satisfaction with the process [Impacto del apoyo emocional durante el parto en la disminucion de cesareas y gratificacion del proceso]. Revista Chilena de Obstetricia y

Ginecologia 1999;64(5):405–12.

References to studies excluded from this review

Bender 1968 {published data only}

Bender B. A test of the effects of nursing support on mothers in labor. ANA Regional Clinical Conferences 1967 Philadelphia/Kansas

City. New York: Appleton-Century-Crofts, 1968:171–9.

Bochain 2000 {published data only}

Bochain SS. Induced labor intervention for self-efficacy: a nursing

intervention for women prone to an unpredictable labor pattern

[thesis]. Rhode Island: University of Rhode Island, 2000.

Brown 2007 {published data only}

Brown H, Hofmeyr GJ, Nikodem VC, Smith H, Garner P. Promoting childbirth companions in South Africa: a randomised pilot study. BMC Medicine 2007;5:7.

Dalal 2006 {published data only}

Dalal R, Rathnakumar, Santamani. Birth companion and mother - a preliminary report [abstract]. 49th All India Congress of Obstetrics and Gynaecology; 2006 Jan 6-9; Kerala State, India. 2006:140. [: 8E10.0007M]

Gordon 1999 {published data only}

Gordon NP, Walton D, McAdam E, Derman J, Gallitero G, Garrett L. Effects of providing hospital-based doulas in health maintenance organization hospitals. Obstetrics & Gynecology 1999;93:422–6.

Hemminki 1990c {published data only}

Hemminki E, Virta AL, Koponen P, Malin M, Kojo-Austin H, Tuimala R. A trial on continuous human support during labor: feasibility, interventions and mothers’ satisfaction. (Trial C - Pilot study with lay women). Journal of Psychosomatic Obstetrics and

Gynaecology 1990;11:239–50.

Lindow 1998 {published data only}

Lindow SW, Hendricks MW, Thompson JW, van der Spuy ZM. The effect of emotional support on maternal oxytocin levels in

17Continuous support for women during childbirth (Review)

labouring women. European Journal of Obstetrics & Gynecology and

Reproductive Biology 1998;79:127–9.

McGrath 1999 {published data only}

McGrath S, Kennell J, Suresh M, Moise K, Hinkley C. Doula support vs epidural analgesia: impact on cesarean rates. Pediatric Research 1999; Vol. 45, issue 4:16A.

Orenstein 1998 {published data only}

Manning Orenstein G. A birth intervention: the therapeutic effects of doula support versus Lamaze preparation on first-time mothers’ working models of caregiving. Alternative Therapies in Medicine

1998;4(4):73–81.

Pinheiro 1996 {published data only}

Pinheiro RT, Sousa PLR, Horta B, de Souza RM, de Sousa MGR, de Sousa FR. Male and female young doulas - effective on labour? [abstract]. Xth World Congress of Psychiatry; 1996 August 23-28; Madrid, Spain. 1996.

Ran 2005 {published data only}

Ran KQ, He AM, Han QR, Tang ZL, Lei FH. Comfortable nursing and the mental state in parturient women. Chinese Journal

of Clinical Rehabilitation 2005;9(32):62–3.

Scott 1999 {published data only}

Scott KD, Klaus PH, Klaus MH. The obstetrical and postpartum benefits of continuous support during childbirth. Journal of

Women’s Health & Gender-Based Medicine 1999;8(10):1257–64.

Sosa 1980 {published data only}

Sosa R, Kennell J, Klaus M, Urrutia J. The effect of a supportive woman on mothering behavior and the duration and complications of labor. Pediatric Research 1979;13:338. ∗ Sosa R, Kennell JH, Klaus MH, Robertson S, Urrutia J. The effect of a supportive companion on perinatal problems, length of labor, and mother-infant interaction. New England Journal of

Medicine 1980;303:597–600.

Trueba 2000 {published and unpublished data}

Trueba G, Contreras C, Velazco MT, Lara EG, Martinez HB. Alternative strategy to decrease cesarean section: support by doulas during labor. Journal of Perinatal Education 2000;9(2):8–13.

Tryon 1966 {published data only}

Tryon PA. Use of comfort measures as support during labor. Nursing Research 1966;15(2):109–18.

Zhang 1996 {published data only}

Zhang CL, Yu ZJ, Feng AH. Study of psychological nursing to ease pain during labour. Chinese Journal of Nursing 1996;31(6):311–3.

References to studies awaiting assessment

Huang 2003 {published data only}

Huang XH, Xiang XY, Shen RG, Shang Q, Zhu LP, Qian X, et al.Study on intrapartum service model during normal labor. Chung-Hua Fu Chan Ko Tsa Chih [Chinese Journal of Obstetrics &

Gynecology] 2003;38(7):385–7.

Additional references

Anim-Somuah 2005

Anim-Somuah M, Smyth R, Howell C. Epidural versus non- epidural or no analgesia in labour. Cochrane Database of Systematic

Reviews 2005, Issue 4. [Art. No.: CD000331. DOI: 10.1002/ 14651858.CD000331.pub2]

AWHONN 2002

Association of Women’s Health, Obstetric, Neonatal Nurses. Professional nursing support of laboring women. http:// www.awhonn.org (accessed 2002).

Caton 2002

Caton D, Corry MP, Frigoletto FD, Hopkins DP, Lieberman E, Mayberry L, et al.The nature and management of labor pain: executive summary. American Journal of Obstetrics and Gynecology

2002;186(5):S1–S15.

Declercq 2002

Declercq ER, Sakala C, Corry MP, Applebaum S, Risher P. Listening to mothers: report of the first national US survey of women’s

childbearing experiences. New York: Maternity Center Association, October 2002.

Declercq 2006

Declercq GD, Sakala C, Corry MP, Applebaum S. Listening to

mothers: report of the second national U.S. survey of women’s

childbearing experiences. New York: Childbirth Connection, 2006.

Higgins 2009

Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2 [updated September 2009]. The Cochrane Collaboration, 2009. Available from www.cochrane- handbook.org.

Hodnett 1997

Hodnett E. Are nurses effective providers of labor support? Should they be? Can they be?. Birth 1997;24:78–80.

Hodnett 2002a

Hodnett ED. Pain and women’s satisfaction with the experience of childbirth: a systematic review. American Journal of Obstetrics and

Gynecology 2002;186(5):S160–S172.

Klaus 2002

Klaus MH, Kennell JH, Klaus PH. The doula book: how a trained

labor companion can help you have a shorter, easier and healthier

birth. 2nd Edition. Cambridge, MA: Perseus Books, 2002.

Lederman 1978

Lederman RP, Lederman E, Work BA, Jr, McCann DS. The relationship of maternal anxiety, plasma catecholamines, and plasma cortisol to progress in labor. American Journal of Obstetrics

and Gynecology 1978;132(5):495–500.

Lederman 1981

Lederman E, Lederman RP, Work BA, Jr, McCann DS. Maternal psychological and physiologic correlates of fetal-newborn health status. American Journal of Obstetrics and Gynecology 1981;139(8): 956–8.

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McGinnis S. On being a doula. MIDIRS Midwifery Digest 2001;11

(3):362–4.

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MIDIRS and the NHS Centre for Reviews and Dissemination. Support in labour: informed choice for professionals leaflet. Midwives Information and Resource Service. Bristol, England, 1999.

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NICE Intrapartum Care 2007

National Collaborating Centre for Women’s and Children’s Health. Section 4.3. Support in labour. Intrapartum care: care of healthy

women and their babies during childbirth. London: RCOG press, September 2007:73–5.

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Pascali-Bonaro D. Global labor support trends. Personal communication 5 June 2010.

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Simkin P. The birth partner: a complete guide to childbirth for dads,

doulas, and all other labor companions. 3rd Edition. Boston: Harvard Common Press, 2007.

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Society of Obstetricians and Gynaecologists of Canada. SOGC policy statement: fetal health surveillance in labour. SOGC News 1995:41–5.

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Labour companionship: every woman’s choice. WHO Reproductive Health Library (http://apps.who.int/rhl/videos/en/ index.html) [accessed 2010].

References to other published versions of this review

Hodnett 2003

Hodnett ED, Gates S, Hofmeyr G J, Sakala. Continuous support for women during childbirth. Cochrane Database of Systematic

Reviews 2003, Issue 3. [Art. No.: CD003766. DOI: 10.1002/ 14651858.CD003766]

∗ Indicates the major publication for the study

19Continuous support for women during childbirth (Review)

C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Breart - Belgium 1992

Methods RCT

Participants 3 trials are reported separately, within 1 publication. Participants were nulliparous, healthy, in spontaneous labour, term, with singleton vertex presentations. Trial in Belgium: n = 264 (133 permanent support; 131 control).

Interventions Permanent presence of a midwife compared to varying degrees of presence. Fathers were allowed to be present.

Outcomes Oxytocin, epidural analgesia, labour length, mode of birth, Apgar scores, mothers’ views of their experiences.

Notes Epidural analgesia was available and it is not known whether electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk Women were ’randomly assigned’. The envelopes were prepared by the coordinating centre. No mention of the process of se- quence generation.

Allocation concealment? Unclear risk Sealed envelopes. No mention if they were opaque or consecu- tively numbered. The process of how the envelopes were opened was not described.

Blinding? All outcomes

Unclear risk No details given.

Incomplete outcome data addressed? All outcomes

Low risk Completion rate for medical record data and in-hospital ques- tionnaire were 99.2% and 91.0% respectively.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

20Continuous support for women during childbirth (Review)

Breart - France 1992

Methods See Breart - Belgium.

Participants See Breart - Belgium. Trial in France: n = 1320 (656 continuous support; 664 control).

Interventions See Breart - Belgium. Fathers were allowed to be present.

Outcomes See Breart - Belgium.

Notes Epidural analgesia was available and it is unknown whether EFM was routine.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk Women were ’randomly assigned’. The envelopes were prepared by the coordinating centre. No mention of the process of se- quence generation.

Allocation concealment? Unclear risk Sealed envelopes. No mention if they were opaque or consecu- tively numbered. The process of how the envelopes were opened was not described.

Blinding? All outcomes

Unclear risk No details given.

Incomplete outcome data addressed? All outcomes

Low risk Completion rate for medical record data and in-hospital ques- tionnaire was > 95%. There were some discrepancies in the total number enrolled. Two reports show 656 in the permanent sup- port group and 664 in the control group for a total of 1320. The table of results in one report shows 654 in the permanent sup- port and 666 in control. The in-hospital questionnaire results are shown for 654 and 664 women (total 1318) but the authors state this is 95% of the sample meaning the total is 1386. The n reported with each outcome was the one used in the data tables in this review.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

Breart - Greece 1992

Methods See Breart - Belgium.

Participants See Breart - Belgium. Trial in Greece: n = 569 (295 permanent support; 274 control).

Interventions See Breart - Belgium. Fathers/family members were not permitted to be present.

21Continuous support for women during childbirth (Review)

Breart - Greece 1992 (Continued)

Outcomes See Breart - Belgium, except that mothers’ views were not reported.

Notes Epidural analgesia was not available. Not stated if electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk Women were ’randomly assigned’. The envelopes were prepared by the coordinating centre. No mention of the process of se- quence generation.

Allocation concealment? Unclear risk Sealed envelopes. No mention if they were opaque or consecu- tively numbered. The process of how the envelopes were opened was not described.

Blinding? All outcomes

Unclear risk No details given.

Incomplete outcome data addressed? All outcomes

Low risk Completion rate for medical record data was 97%. No in-hos- pital questionnaire data were available.

Free of selective reporting? Low risk All medical record outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

Bruggemann 2007

Methods RCT.

Participants 212 nulliparous women in active labour at term (105 support group, 107 control group) at a University-affiliated hospital in Sao Paulo Brazil. To be eligible a companion of the woman’s choosing had to be available. 49.5% of the companions were present at enrolment and the others were phoned and asked to come to the hospital (4 failed to make it before delivery).

Interventions Support was ’presence of a chosen companion during labour and delivery’. ’The com- panions received verbal and written information on the activities involved in providing support, expected behaviour when confronted with signs of tiredness, anxiety, concern, crying, screaming and/or the woman’s feelings of inability to cope, compliance with regulations and the possibility of requesting information from staff ’. in 47.6% of the sample the woman’s companion was her partner, for 29.5% it was her mother. The control group received usual care where a companion during labour and delivery was not permitted. For both groups labour and delivery care was provided ’according to the routine protocol including active management of labour (early amniotomy, use of oxytocin, intermittent electronic fetal monitoring and systematic analgesia)’.

22Continuous support for women during childbirth (Review)

Bruggemann 2007 (Continued)

Outcomes Satisfaction with labour and delivery, perinatal and breastfeeding outcome in the 12 hours post delivery.

Notes All women in labour at this hospital received epidural analgesia as a routine practice. Therefore we did not include epidural analgesia data in the Review. Electronic fetal monitoring was not used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Low risk ”Computer generated sequence of random numbers’.

Allocation concealment? High risk ’Individual assignment numbers were all placed in an opaque container to assure the concealment. The eligible women who had agreed to participate selected one of the numbers once, and were therefore allocated to either intervention group or control according to the list.’ This process was open to selection bias as women could have re- picked another number from the container. No audit process is possible with this system of randomization.

Blinding? All outcomes

High risk Data collection by author, who knew group allocation.

Incomplete outcome data addressed? All outcomes

Low risk Medical record data were collected and in-hospital question- naires were completed for 100% of sample.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

Campbell 2006

Methods RCT.

Participants 600 nulliparous, low-income, under-insured pregnant women (300 doula group, 300 control group) booked for delivery at a hospital in New Jersey, USA were enrolled between 12 and 38 weeks’ gestation. They were considered low risk, with no contraindications to labour and had a female friend or relative willing to act as their lay doula. The doula was in addition to support people of their own choosing.

Interventions Intervention: continuous support by a female friend or relative who had had 2, 2-hour sessions about labour support. The training sessions were conducted for nearly all of the lay caregivers when the participants were 34-36 weeks’ gestation. Control group: support people of their own choosing.

23Continuous support for women during childbirth (Review)

Campbell 2006 (Continued)

Outcomes Labour length, epidural analgesia, oxytocin augmentation, cervical dilation at epidural insertion, length of second stage labour, caesarean birth, 1-min Apgar score > 6, 5-min Apgar score > 6.

Notes Epidural analgesia was available and electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Low risk ’Computer generated randomization scheme’.

Allocation concealment? Low risk Consecutively-numbered, sealed opaque envelopes contained treatment assignments..After obtaining consent, a research as- sistant opened the next envelope. It was unclear whether the research assistant enrolling the woman was the same one that opened the envelope.

Blinding? All outcomes

High risk Medical record abstraction was done by the author who was not blinded. The six-week questionnaire data collection was not blinded.

Incomplete outcome data addressed? All outcomes

High risk Medical record information was completed for 97.7% of the sample (82.3% in the intervention group and 94.3% in the con- trol group). The differential rates are due to withdrawals from the intervention group for doula related reasons (incomplete training and not being present during labour). The 6-week ques- tionnaire was completed for 82.3% of the sample. Only those women included in the study at delivery had the opportunity to complete the questionnaire and thus the differential completion rate between groups remained (76.3% in the intervention group and 88.3% in the control group). The differential withdrawals could introduce selection bias.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Unclear risk The training of the doulas giving the intervention was done by the research assistant, who was herself a doula. This same research assistant enrolled all study participants.

Cogan 1988

Methods RCT.

Participants 34 women (primigravidas and multigravidas) at 26-37 weeks’ gestation in 2 Texas hos- pitals (20 to supported group and 14 to usual care). They were in early, uncomplicated preterm labour.

24Continuous support for women during childbirth (Review)

Cogan 1988 (Continued)

Interventions Intervention: support provided by a Lamaze childbirth preparation instructor. Support included continuous presence, acting as a liaison with hospital staff, providing informa- tion, and teaching relaxation and breathing measures. Usual care: intermittent nursing care. Family members allowed to be present.

Outcomes Fetal distress, caesarean birth, artificial oxytocin, labour length, Apgar scores, neonatal intensive care.

Notes Not stated if epidural analgesia was available or if electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk ’Randomly assigned’. No further details provided.

Allocation concealment? Unclear risk Admitting nurse telephoned research assistant to obtain treat- ment allocation. No details about whether the research assistant had foreknowledge of the treatment allocation scheme.

Blinding? All outcomes

Low risk Medical record information collected by ’research assistants who did not know the group membership of the women’.

Incomplete outcome data addressed? All outcomes

High risk Withdrawals occurred before analysis (6 (30%) in support group and 3 (21%) in control). This resulted in a follow-up rate of 73.5%. The withdrawals were done differentially in the support group, i.e. some women were withdrawn because of an event that occurred before the support person arrived. Women in the control group with the same event were not withdrawn. We were able to re-create the original study groups for one outcome only, caesarean birth, and therefore it is included in the analysis table.

Free of selective reporting? Unclear risk No outcomes were stated a priori.

Free of other bias? Low risk No other sources of bias noted.

Dickinson 2002

Methods RCT, stratified by induced or spontaneous labour at trial entry.

Participants 992 nulliparous women at term (499 to continuous support and 493 to control), cephalic fetal presentation, cervical dilatation < 5 cm, in a hospital in Perth, Western Australia.

Interventions Group 1: continuous physical and emotional support by midwifery staff, and women were encouraged to use pharmacologic and nonpharmacologic alternatives to epidural analgesia.

25Continuous support for women during childbirth (Review)

Dickinson 2002 (Continued)

Group 2: continuous midwifery support was not provided and women were encouraged to have epidural analgesia as their primary method of pain relief in labour.

Outcomes Labour length (expressed as median and interquartile range), epidural analgesia, mode of delivery, 5 min Apgar score < 7, arterial cord pH.

Notes The stated purpose was to compare the effects of intrapartum analgesic techniques on labour outcomes. Continuous midwifery support was conceptualized as an analgesic technique. Both groups had access to opioids and nitrous oxide. No data were presented about the number of women who used no pharmacologic analgesia. Because the type of analgesia used was a measure of compliance rather than an outcome, no data on analgesic outcomes are included in this Review. It was not stated if other support person was allowed. epidural analgesia was available and electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk No details about how the blocks of treat- ment allocations were produced.

Allocation concealment? Unclear risk Randomization on presentation in the labour and delivery unit, “by selection from a blocked group of eight sealed opaque en- velopes, replenished from blocks of 12”. No further details about process.

Blinding? All outcomes

Unclear risk Not noted.

Incomplete outcome data addressed? All outcomes

Low risk There was 100% follow-up for medical record data and in-hospital survey. A 6- month questionnaire was completed by 64.7% of the sample and these data were not used.

Free of selective reporting? Low risk All main outcomes were reported. Effects on breastfeeding were not analyzed by treat- ment group and thus the results could not be included in the review.

Free of other bias? Low risk No other sources of bias noted.

26Continuous support for women during childbirth (Review)

Gagnon 1997

Methods RCT.

Participants 413 women admitted to an intrapartum unit at a tertiary care teaching hospital in Mon- treal, Canada, were randomly allocated to experimental (n = 209) or control (n = 204) groups. All but 3 in the experimental group and 6 in the control group were accompa- nied by a spouse, relative or friend during labor. All participants were nulliparous, with singleton fetuses, > 37 weeks’ gestation, and in labour.

Interventions Experimental: one-to-one nursing care from randomization until 1 hour postbirth. Care was provided by on-call nurses who were hired specifically for the study and had received a 30-hour training program and quarterly refresher workshops. The training program included critical reviews of the literature concerning the effects of intrapartum medical and nursing practices, as well as discussions of stress and pain management techniques. The nurse provided the usual nursing care plus physical comfort, emotional support, and instruction on relaxation and coping techniques. The nurse took meal breaks and brief rest breaks. Women in the comparison group received usual nursing care by the regular unit staff, consisting of intermittent support and monitoring.

Outcomes Caesarean birth, caesarean birth for cephalopelvic disproportion or failure to progress, post-randomization artificial oxytocin augmentation, post-randomization analgesia/ anaesthesia, instrumental vaginal delivery (forceps or vacuum extraction), NICU admis- sion, perineal trauma, mean duration of labour post-randomization, postpartum urinary catheterization.

Notes The participants had been admitted to the unit for an average of 5 hours (SD = 4 hours) prior to randomization. 36 women in the experimental group and 41 in the control group had epidural analgesia prior to randomization. 55 women in the experimental group and 45 in the control group had intravenous oxytocin augmentation of labour prior to randomization. Mean duration of labour post-randomization was 9.2 hours (SD = 4.3). Epidural analgesia was available but it was not stated if electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Low risk ’Randomized using a list of computer generated random num- bers’.

Allocation concealment? Low risk ’Randomized in blocks of eight’. ’Group assignments were placed in sequentially numbered, sealed, opaque envelopes’.

Blinding? All outcomes

High risk Data collectors were not blinded as they read nurses notes to collect data.

Incomplete outcome data addressed? All outcomes

Low risk 100% follow-up.

27Continuous support for women during childbirth (Review)

Gagnon 1997 (Continued)

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

Hemminki 1990a

Methods Two RCTs reported in the same publication. The Zelen method was used: only those participants randomized to the experimental group were told the true purpose of the trial and asked for consent. The participants in the control group were told about the study in the introduction letter for the postpartum questionnaire and they were told it was ’a study on factors influencing birth’.

Participants Healthy nulliparous and parous women in labour at a hospital in Finland. 86 women were enrolled in Trial A. The actual number enrolled to each group was not noted but medical record data were collected for 79 women (41 in the support group and 38 in the control group). These 79 women represented 91.9% of the total sample.

Interventions Trial A: in 1987, the intervention was 1:1 support by midwifery students from enrolment until transfer to the postpartum ward. The midwifery students volunteered, were not specially trained in support and responsible for the other routine intrapartum care. The control group ’was cared for according to the normal routine of the midwife and by a medical student, if s(he) was on duty’. Over 70% of fathers were present.

Outcomes Labour length, medical interventions, complications (mother and baby), pharmacologic pain relief, method of birth, mothers’ evaluations of their experiences.

Notes Not stated if epidural analgesia was available or if electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk No mention of how the allocation sequence was produced.

Allocation concealment? Unclear risk ’Randomization coding was done in blocks of 6 and put into non-transparent en- velopes. The envelope was opened at the re- ception ward when it was decided to trans- fer mother to labour ward.’ It was not stated if the envelopes were consecutively num- bered.

Blinding? All outcomes

High risk Medical record outcome were collected un- blinded.

28Continuous support for women during childbirth (Review)

Hemminki 1990a (Continued)

Incomplete outcome data addressed? All outcomes

Low risk Medical record data were collected on 91.9% of the sample. A questionnaire was administered at 2-3 days postpartum. This was completed by only 70% of the sample and thus the data were not used.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? High risk Mothers were told the purpose of the study differentially (see methods for Trial A above).

Hemminki 1990b

Methods See Hemminki 1990a.

Participants See Hemminki 1990a. 161 women were enrolled in Trial B (81 in the support group and 80 in control).

Interventions Trial B: in 1988, the intervention was support by a new group of midwifery students. All students were involved in the trial, not just volunteers. The students were permitted to leave their participants to witness other interventions and deliveries. The control group ’was cared for according to the normal routine of the midwife’ and by a medical student as enrolment was limited to days when medical students were on duty. Slightly less than 70% of fathers were present.

Outcomes See Hemminki 1990a.

Notes Not stated if epidural analgesia was available or if electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk No details provided.

Allocation concealment? Unclear risk The block size was reduced from the first study. ’To lessen the frustration resulting from opening a code for a control mother, randomization envelopes contained a maximum of two sim- ilar codes in sequence (not told in advance)’. ’Put into non- transparent envelopes’. The envelope was opened in the labour ward. It was not stated if the envelopes were consecutively numbered.

Blinding? All outcomes

High risk Medical record outcome were collected unblinded.

29Continuous support for women during childbirth (Review)

Hemminki 1990b (Continued)

Incomplete outcome data addressed? All outcomes

Low risk Medical record data were collected on 100% of the sample. A questionnaire was administered at 2-3 days postpartum and completed by 93.7% of the sample.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? High risk Mothers were told the purpose of the study differentially (see methods for Trial A above).

Hodnett 1989

Methods RCT, stratified by type of prenatal classes (Lamaze versus general).

Participants 145 nulliparous women (72 to support group and 73 to control) in the last trimester of a healthy pregnancy, booked for delivery at a Toronto, Canada, hospital.

Interventions Support provided by a monitrice (community ’lay’ midwife or midwifery apprentice) compared to usual hospital care, defined as the intermittent presence of a nurse. Support described as including physical comfort measures, continuous presence, information, emotional support, and advocacy. The monitrice met with the woman twice in the latter weeks of pregnancy, to discuss her birth plans. Comparable prenatal attention was provided to the controls. All but 1 woman also had husbands or partners present during labour. Support began in early labour at home or in hospital and continued through delivery.

Outcomes Intrapartum interventions, perceived control, method of delivery.

Notes Epidural analgesia was available and EFM was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Low risk Computer-generated table of random numbers.

Allocation concealment? High risk Randomization done over the phone by a third party who had no knowledge of the participant, but used the open table of ran- dom numbers

Blinding? All outcomes

Low risk All participants blinded to the interven- tion. Control participants received prenatal and postpartum support (after the end of data collection); experimental participants received prenatal and intrapartum support. Initial collection of medical record data

30Continuous support for women during childbirth (Review)

Hodnett 1989 (Continued)

was not blinded. ’Duplicate abstraction was done by a second research assistant blind to the subject’s study group assignment, on a random sample of 20 records. Interrater agreement of over 95% was obtained for all categories of intervention and physical outcomes.’ In-home interview at 2-4 weeks postpartum was blinded.

Incomplete outcome data addressed? All outcomes

Low risk Method of delivery outcome available on 88.3% of sample. Other outcomes col- lected on only 71% of the sample and thus not used.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

Hodnett 2002

Methods Multi-centre RCT with prognostic stratification for parity and hospital.

Participants 6915 nulliparous and parous women in labour at 13 hospitals in the USA and Canada (3454 to continuous labour support and 3461 to usual care). Eligibility criteria: live singleton fetus or twins, no contraindications to labour, in labour. Women were excluded if gestational age was < 34 weeks or if they were so high risk that a 1:1 patient-nurse ratio was medically necessary.

Interventions Experimental: continuous support from staff labour and delivery nurses who had volun- teered for and received a 2-day training workshop in labour support. Prior to the trial, the support nurses had opportunities to practice their skills. They also had opportunities to continue learning from each other and the labour support trainer, throughout the trial. The nurses with training were part of the regular staffing complement of the unit and they provided care to the continuous support group but not to the usual care group. Usual care: intermittent support from a nurse who had not received labour support training.

Outcomes Intrapartum interventions, method of birth, immediate complications (mother or baby) , complications (mother or baby) in the first 6-8 weeks postpartum, perceived control, postpartum depression, breastfeeding at 6-8 weeks, relationship with partner and with baby, likes and dislikes about birth experience and future preferences for labour support.

Notes Other support person(s) were allowed, epidural analgesia was available and electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

31Continuous support for women during childbirth (Review)

Hodnett 2002 (Continued)

Adequate sequence generation? Low risk Computerized randomization program.

Allocation concealment? Low risk ’Randomization was centrally controlled with the use of a computerized random- ization program at the data coordinating centre, accessible by means of a touch-tone telephone.’

Blinding? All outcomes

Low risk Data collectors were not blinded as they read nurses’ notes to collect data about type of nursing care provided. However random chart audits yielded no errors in reporting study outcomes.

Incomplete outcome data addressed? All outcomes

Low risk Medical record data were collected on 100% of the sample. In-hospital question- naires were completed by 96.4% and 6-8 week questionnaires by 81% of the sample.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

Hofmeyr 1991

Methods RCT.

Participants 189 nulliparous women (92 to support and 97 to control) in active labour at a community hospital serving low-income women in South Africa.

Interventions Intervention group: support by carefully trained, volunteer lay women, for at least several hours (supporters not expected to remain after dark). Control group: intermittent care on a busy ward. Husbands/family members were not permitted.

Outcomes Intrapartum interventions, method of birth, complications (mother and baby), anxiety, pain, mothers’ perceptions of labour, breastfeeding.

Notes Epidural analgesia was not available and electronic fetal monitoring was not used rou- tinely. While scores on an instrument measuring postpartum depression were reported in categories of ”low“, ”moderate,“ and ’high”, the authors stated that categorization was not appropriate as a clinical diagnostic definition of depression. To achieve the latter, the change in score must be reported, and these data were not collected.

Risk of bias

Bias Authors’ judgement Support for judgement

32Continuous support for women during childbirth (Review)

Hofmeyr 1991 (Continued)

Adequate sequence generation? Low risk Random.

Allocation concealment? Unclear risk “Randomly ordered cards in sealed opaque envelopes”. Not stated if consecutively numbered.

Blinding? All outcomes

High risk Data collectors were not blinded as they asked questions about support received in labour.

Incomplete outcome data addressed? All outcomes

Low risk Medical record data were collected on 100% of the sample and questionnaires within 24 hours postpartum were completed by 99%. The 6-week follow-up interviews were completed by 78.8% of the sample, no imbalances existed between groups and thus the data were included in the analysis. At 1-year interviews were complete for 46% of the sample and data from these were not used. Nikodem reported on a larger sample of women with 1-year follow-ups but the completion rate was still only 50% of the original number enrolled.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

Kashanian 2010

Methods RCT.

Participants 100 nulliparous women at term (50 to support and 50 to routine care) in active labour at a university hospital in Tehran, Iran from March to September 2003.

Interventions ’Women allocated to the intervention group were shown to an isolated room and were supported by an experienced midwife. The women were free to choose their position, and able to eat and walk about freely. During labor, the midwife explained the process of labor and the importance of body relaxation. Midwife-led support included close physical proximity, touch, and eye contact with the laboring women, and teaching, reassurance, and encouragement. The midwife remained with the woman throughout labor and delivery, and applied warm or cold packs to the woman’s back, abdomen, or other parts of the body, as well as performing massage according to each woman’s request. ’ ’Women allocated to the routine care group were admitted to the labor ward (where 5-7 women labour in the same room), did not receive continuous support, and followed the routine orders of the ward. They did not have a private room, did not receive one-to- one care,were not permitted food, and did not receive education and explanation about the labor process. The only persons allowed in the delivery room were nurses, midwives, and doctors.’

Outcomes Duration of labour, caesarean delivery, oxytocin use, Apgar score at 5 minutes

33Continuous support for women during childbirth (Review)

Kashanian 2010 (Continued)

Notes Electronic fetal monitoring was not used routinely and epidural analgesia was not avail- able.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Low risk From personal communication - equal numbers of envelopes were produced for each letter (see below) and put into a box. No list of treatment allocations was created.

Allocation concealment? High risk ’Allocated to one of two groups using 4-part, block randomiza- tion’. Used ’sealed envelopes labelled A, B, C, and D: envelopes A and C (intervention group) and B and D (routine care group) . Patients then chose an envelope, which was opened by the in- vestigator’. Further details from personal communication - the women picked from all the envelopes produced. Once an envelope was picked it was discarded. This process was open to selection bias as women previously in the trial may have shared knowledge of which envelope con- tained which group with women not yet enrolled in the study.

Blinding? All outcomes

Low risk From personal communication - ’The co worker of investiga- tor collected the outcome data and she was blind for the study group.’

Incomplete outcome data addressed? All outcomes

Low risk Medical record information was collected on 100% of the sam- ple.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

Kennell 1991

Methods RCT of continuous support vs usual care with an ’inconspicuous observer’ plus a ret- rospective non-random control group. This review is restricted to comparisons of the outcomes of the participants who were randomly assigned.

Participants 412 nulliparous women (212 in support group and 200 in observed group) were part of the RCT. They were aged 13-34, with singleton, term, healthy pregnancies, many not English-speaking, in active labour at a public hospital in Texas which provides care for low-income patients .

Interventions The description of the setting, the participants, and the type of care echo developing world conditions. All women laboured in a large 12-bed room. For the women in the support group a doula stayed by their bedside and gave continuous

34Continuous support for women during childbirth (Review)

Kennell 1991 (Continued)

support. For those in the observed group they had the routine intermittent presence of a nurse and continuous presence of an ’inconspicuous observer’ who ’kept a record of staff contact, interaction and procedures’. The observer was away from the beside and never spoke to the labouring woman.

Outcomes Analgesia/anaesthesia, labour length, artificial oxytocin use, method of birth, complica- tions (mother and baby), neonatal health, number of women who rated their experience as negative.

Notes In instances in which outcome data (such as analgesia/anaesthesia use) in the published report were only provided for subgroups, the primary author was contacted and he provided complete outcome data for all women who were originally randomized. Family members were not allowed to be present. Epidural analgesia was available and electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk Described as random.

Allocation concealment? Low risk ’Randomly assigned’ is stated in the report. In the protocol for the trial it states ’num- bered opaque envelopes’ would be used. The envelopes ’would contain the random assignments of the women to control or treatment groups and would be numbered sequentially’.

Blinding? All outcomes

Unclear risk Not stated.

Incomplete outcome data addressed? All outcomes

Low risk There is some discrepancy in the number of women enrolled in the study. The report states 412 were enrolled and reports out- come data on all 412 women. But it also states that ’14 women that agreed to partic- ipate were not included in the study.’ The reasons for not including them seem to be events that would happen after randomiza- tion - e.g. transferred due to staffing limita- tions, withdrew, undetected breech, inter- rupted observations, etc., and thus the sam- ple appears to have numbered 426. Data are reported for 412 women (96.7% of 426).

Free of selective reporting? Low risk All outcomes were reported.

35Continuous support for women during childbirth (Review)

Kennell 1991 (Continued)

Free of other bias? Low risk No other sources of bias noted.

Klaus 1986

Methods RCT. Purposefully enrolled more women to the control group. See risk of bias table below.

Participants 465 healthy nulliparous women (186 to support group and 279 to control) in labour at the Social Security Hospital in Guatemala.

Interventions Support group: continuous emotional and physical support by a doula. Control group: usual hospital routines (described as no consistent support).

Outcomes Labour length, use of artificial oxytocin, method of birth, problems during labour and birth, fetal distress, Apgar scores, transfer to neonatal intensive care nursery.

Notes No family members permitted to be present. epidural analgesia was not available and electronic fetal monitoring was not used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk ’Enrolled using randomised design’. ’Pool of envelopes contained more control group to ensure similar sized groups with uncom- plicated labours and deliveries.’ They antic- ipated more complications in control group based on an earlier study (Sosa 1980). No information on how allocation sequence was generated.

Allocation concealment? Low risk ’Randomly assigned according to contents of a sealed opaque envelope. Each envelope was numbered sequentially.’

Blinding? All outcomes

Unclear risk Not noted.

Incomplete outcome data addressed? All outcomes

Low risk ’Mother-infant pairs were excluded when the mother developed a complication dur- ing labour, delivery, or post partum that re- quired special care, if the baby’s weight was below 5.5 lbs or above 8 lbs, if there were twins or congenital malformations.’ This occurred for about 10% of cases in both groups resulting in reported outcomes for 89.6% of those randomized. Unpublished

36Continuous support for women during childbirth (Review)

Klaus 1986 (Continued)

data on the excluded women were provided by the author. Labour length data were only available for 48.4% of the sample (225 of 465) and thus not included.

Free of selective reporting? Low risk All outcomes were reported on.

Free of other bias? Low risk No other sources of bias noted.

Langer 1998

Methods RCT.

Participants 724 women (361 to support and 363 to control) admitted for delivery at a large social security hospital in Mexico City, who met the following criteria: singleton fetus, no previous vaginal delivery, < 6 cm cervical dilatation, and no indications for an elective caesarean delivery.

Interventions Support group: continuous support from 1 of 10 women who had received doula training (6 were retired nurses), throughout labour, birth, and the immediate postpartum period. Support included: emotional support, information, physical comfort measures, social communication, ensuring immediate contact between mother and baby after birth, and offering advice about breastfeeding during a single brief session postnatally. Control group: women received ’routine care’.

Outcomes The main outcomes were exclusive and full breastfeeding at 1 month postpartum. Other outcomes included labour length, epidural anaesthesia, forceps birth, caesarean birth, meconium staining, and Apgar scores, as well as mothers’ perceived control during childbirth, anxiety, pain, satisfaction, and self-esteem.

Notes Partners and family members were not permitted. Epidural analgesia was available but it was not stated if electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Low risk ’Computer generated random number list’. ’The treatment se- quence was kept at a central level.’

Allocation concealment? Unclear risk ’Opaque envelopes with the assignment were locked in a cabinet to which only a social worker exclusively in charge of randomisa- tion and the principal investigator had access. An envelope with a paper inside showing to which group each woman was assigned was opened by the social worker immediately after recruitment in the labour and delivery unit. Not stated if envelopes were sequentially numbered.

37Continuous support for women during childbirth (Review)

Langer 1998 (Continued)

Blinding? All outcomes

Low risk Data were collected by 2 ’blinded social workers’.

Incomplete outcome data addressed? All outcomes

Low risk Medical record data and in-hospital interview data were collected for 100% of the sample. A in-home interview was completed at one month postpartum for 92.2% of the sample.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

Madi 1999

Methods RCT.

Participants 109 Black women from Botswana (53 in support group and 56 in usual care group) , mean age 19 years, 80% unmarried, mostly students, who had met the following criteria: nulliparous, in labour, pregnancy at term, no history of pregnancy complications, cephalic presentation, normal spontaneous labour with cervical dilation 1-6 cm, female relative present who was willing to remain with the woman for the duration of labour.

Interventions Support group: continuous presence of female relative (usually her mother) in addition to usual hospital care Congrol group: usual hospital care, which involved staff:patient ratios of 1:4, and no companions permitted during labour.

Outcomes Spontaneous vaginal birth, vacuum extraction, caesarean birth, analgesia, amniotomy, artificial oxytocin during labour, Apgar scores (1- and 5-min).

Notes Epidural analgesia was not available and it was not stated whether electronic fetal mon- itoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk ’Randomly allocated.’ No other details provided.

Allocation concealment? Low risk ’Selection of an opaque, numbered, sealed envelope from a box of envelopes that were shuffled in the woman’s presence. When opened the envelope revealed a code indicating her group.’ An assistant that was not involved in the recruitment process shuf- fled the envelopes.

Blinding? All outcomes

High risk The researcher, who was involved in the recruitment of partici- pants, collected the medical record data.

38Continuous support for women during childbirth (Review)

Madi 1999 (Continued)

Incomplete outcome data addressed? All outcomes

Low risk Medical record data were collected on 100% of the sample.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

McGrath 2008

Methods RCT. Enrollment occurred at childbirth education classes and randomization occurred when the woman arrived at hospital in labour.

Participants 420 nulliparous middle and upper class women (224 on doula group and 196 in control group) were enrolled in the third trimester of an uncomplicated pregnancy in Cleveland, Ohio. All women expected to be accompanied during labor by their male partner.

Interventions Experimental group: A doula met the couple at the hospital as soon as possible after random assignment (typically within an hour of their arrival at the hospital) and remained with them throughout labor and delivery. The central component of doula support was the doula’s continuous bedside presence during labor and delivery, although her specific activities were individualized to the needs of the labouring woman. Doula support included close physical proximity, touch, and eye contact with the labouring woman, and teaching, reassurance, and encouragement of the woman and her male partner. All doulas completed training requirements that were equivalent to the DONA International doula certification. Control group: routine obstetric and nursing care which included the presence of a male partner or other support person.

Outcomes Caesarean delivery, epidural anaesthesia, oxytocin use, labour length, mode of delivery, fever during labour, satisfaction at 6 weeks postpartum.

Notes Epidural analgesia was available and electronic fetal monitoring was used routinely. The author has been contacted for data split by study group and questionnaire data for the control group.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk No details stated.

Allocation concealment? Low risk ’When the research coordinator was in- formed that an enrolled woman had ar- rived at the hospital in early active labor, she opened the next sequentially numbered opaque envelope to determine random as- signment to the doula or control group’.

39Continuous support for women during childbirth (Review)

McGrath 2008 (Continued)

The research coordinator was off-site and called by the staff or the study participant.

Blinding? All outcomes

Unclear risk Not stated.

Incomplete outcome data addressed? All outcomes

Low risk Medical record data were collected on 100% of the sample. The in-hospital and 6-week questionnaires were completed by 87.9% and 87.5% of the doula group. No information was provided for the control group.

Free of selective reporting? Low risk The primary outcomes of caesarean birth and epidural anaesthesia were reported for each study group. Other labour and de- livery outcomes were reported for the full sample only (not split by group). The in-hospital and 6-week questionnaire data were only reported for the doula group. The author has been contacted for these miss- ing details.

Free of other bias? Low risk No other sources of bias noted.

Morhason-Bello 2009

Methods RCT.

Participants 603 women from Ibadan, Nigeria with anticipated vaginal delivery were enrolled between 30 and 32 weeks’ gestation at an antenatal clinic (305 to intervention and 298 to control) from November 2006 to March 2007.

Interventions Those in the experimental group were informed to bring someone of their choice to act as a companion during labour. On arrival in labour the accompanying companions were provided with an information leaflet that explained their responsibilities. These included: gentle massage of the woman’s back during contraction, reassuring words, spiritual support inform of prayers and also acting as intermediary between the woman and healthcare team. After studying the leaflets, they were allowed to seek clarifications. The information leaflet was also interpreted for those that are not literate. The attending midwife allowed and ensured companions performed their expected duties throughout. The companions were told to offer continuous support - they were to be by the patient’s side except for feeding and use of toilet until two hours after childbirth. Husbands were the most common support person (65.4%). The women in the control group had only routine care where relatives of patients are usually barred from the labour ward.

40Continuous support for women during childbirth (Review)

Morhason-Bello 2009 (Continued)

Outcomes Caesarean section rate, active phase of labour duration, pain score, need for analgesia, need for oxytocin augmentation, time from delivery to initiation of breastfeeding and the emotional experience during labour.

Notes Epidural analgesia was not available and it was not stated whether electronic fetal mon- itoring was used routinely. We have requested further details from the authors. The randomization process was well done, but resulted in an imbalance in socioeconomic status between the groups. Women in the experimental group tended to be more educated (82% vs 48% with tertiary level) and skilled workers (78% vs 39%). This imbalance was noted and discussed by the authors.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Low risk ’The randomisation sequence was generated using a table of random numbers’.

Allocation concealment? Low risk ’Random permuted blocks of size four were used to ensure a bal- anced design.’ ’Based on the sequence of treatments generated using this method, treatment groups (A and B) were written on pieces of cardboard paper and put into sealed opaque envelopes. Each of the opaque envelopes had a serial number on it.’ ’Two trained research assistants (RAs) non-medical staff, supervised the randomisation procedure at every clinic. On each clinic day, consented women that met the inclusion criteria were given se- rial numbers with allotted treatment group based on their arrival time. Only the statistician and RAs had access to the list of num- bers used to prevent clinicians’ influence on the randomisation. Each participant opened the opaque envelope in the presence of an RA, and the assigned treatment group was recorded on the woman’s medical record file.’

Blinding? All outcomes

High risk How data collection was done was not noted. The treatment group was noted in the chart so it is likely that the data collectors were unblinded.

Incomplete outcome data addressed? All outcomes

Low risk Follow up was completed for 97% of the sample.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

41Continuous support for women during childbirth (Review)

Thomassen 2003

Methods RCT, no details regarding method of random assignment.

Participants 144 ’healthy’ women having their first baby booked for delivery at a Swedish hospital (72 to doula group and 72 to usual care). Participants were enrolled at 36 weeks’ gestation.

Interventions Continuous presence by a doula who had met the woman during pregnancy, compared to usual care.

Outcomes Emergency caesarean birth and epidural analgesia.

Notes The trial author reported that the information about randomization method and out- comes of those lost to follow-up are no longer available. Epidural analgesia was available. It was not stated if other support person(s) were allowed or if electronic fetal monitoring was used routinely.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Unclear risk ”Randomized’ - no further details provided or available.

Allocation concealment? Unclear risk No details provided or obtained.

Blinding? All outcomes

Unclear risk Not noted.

Incomplete outcome data addressed? All outcomes

High risk Medical record data collected on 70.1% of sample. No usable outcome data, due to serious risk of attrition bias. Outcomes are reported for 55/72 (76%) of the interven- tion group and 46/72 (64%) of the control group. Reason for the 41 “dropouts” were preterm birth, induction, or caesarean sec- tion “for medical reasons”, and participant withdrawal. No numbers are given for in- dividual reasons, or by group, but it is clear that some “dropouts” were prior to labour and others were during labour. Numbers in the report show the number of dropouts was actually 43.

Free of selective reporting? Unclear risk Sample size was based on caesarean section rate. The only outcome reported was emer- gency caesarean.

Free of other bias? High risk Trial was stopped early for ’a range of largely organizational issues’ when only 1/4 of the original sample size had been enrolled.

42Continuous support for women during childbirth (Review)

Torres 1999

Methods RCT

Participants 435 women (217 in companion group, 218 in control group) with a singleton pregnancy and considered to be low-risk at University Hospital in Santiago, Chile. Enrolled at 34- 36 weeks’ gestation.

Interventions Intervention group: psychosocial support during labour from a companion chosen by the pregnant woman. The companions were trained by trial staff to provide emotional support, promote physical comfort and encourage progress of labor, without interfering with the activities of the obstetricians or midwives. They were with the labouring woman continuously from admission to delivery. Women were encouraged to pick a companion who had experienced a vaginal birth. Control group did not have companion. Both groups laboured in a room with other women where curtains were pulled for privacy.

Outcomes Caesarean section, exclusive breastfeeding, duration of labour, mode of delivery, use of oxytocics, presence of meconium, regional anaesthesia, birth asphyxia, Apgar scores, level of neonatal care, maternal satisfaction.

Notes Epidural analgesia was available. It was not stated if electronic fetal monitoring was used routinely. Authors have been contacted for further details.

Risk of bias

Bias Authors’ judgement Support for judgement

Adequate sequence generation? Low risk Computer generated list of random numbers.

Allocation concealment? Low risk Used blocks of 6. Group assignment used sealed opaque en- velopes numbered consecutively. A member of the trial team en- rolled women and did not know in advance the content of each envelope.

Blinding? All outcomes

Unclear risk Not stated.

Incomplete outcome data addressed? All outcomes

Low risk Medcial record data were collected for 100% of the sample and in-hospital surveys were completed by 95.8%. A 6-week phone interview was completed for 71.2% of the sample and thus these data were not used.

Free of selective reporting? Low risk All outcomes were reported.

Free of other bias? Low risk No other sources of bias noted.

EFM: electronic fetal monitoring min: minutes

43Continuous support for women during childbirth (Review)

NICU: neonatal intensive care unit RCT: randomized controlled trial SD: standard deviation vs: versus

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Bender 1968 2 studies are reported, n = 12 in the first study and n = 30 in the second. Neither one was an RCT. Both employed alternate allocation that was neither centrally controlled nor concealed. The researcher delivered the intervention and collected outcome data. In the first study the researcher also enrolled participants. No usable outcome data are reported.

Bochain 2000 The intervention was not continuous labour support. It was a short nursing intervention (taking approximately 1 hour) administered in early labour for women undergoing Misoprostol induction.

Brown 2007 The intervention was not continuous labour support. It was an educational intervention to promote childbirth companions in hospital deliveries. A cluster RCT was done at 10 South African state maternity hospitals.

Dalal 2006 Not an RCT. 100 randomly-selected mothers who had a birth companion were compared to 50 randomly- selected mothers who did not have one. Mothers were matched for age and socioeconomic status.

Gordon 1999 30% of those enrolled were excluded post-randomization, 73/232 in the doula group and 69/246 in the control group. A letter was sent to the first author, asking for data on the excluded participants that would permit an intent-to-treat analysis. If and when a response is received, we will evaluate the trial report again.

Hemminki 1990c Third study in the same report as Hemminki 1990a and 1990b. This was a small pilot RCT of support by laywoman that was ’stopped for economic and other practical reasons’. 31 women were enrolled but 7 dropped out (all from the intervention group). Very little data were reported and it was not separated by treatment group and thus unusable.

Lindow 1998 Support was not continuous, and was quite brief in duration. 16 women in active labour were randomized to either 1 hour with a supportive companion or 1 hour without. The only outcome was maternal oxytocin level for 16 minutes post-support or control period.

McGrath 1999 An abstract outlining a study of 531 women in Houston, Texas. Insufficient details to permit evaluation of the quality of the trial, and insufficient details regarding results. Thus far, attempts to locate a full report of the trial have been unsuccessful.

Orenstein 1998 Not a randomized trial. Women chose to either have a doula or have Lamaze preparation for childbirth.

Pinheiro 1996 An abstract of a paper presented at the Xth World Congress of Psychiatry in Madrid, 1996. Preliminary results were reported. Efforts to locate a published report of the full trial have been unsuccessful. The abstract provides insufficient details regarding methods, to permit evaluation of the quality of the trial. The purpose was to compare the effectiveness of female vs male doulas vs routine care without doulas. The doulas were medical and psychology students.

44Continuous support for women during childbirth (Review)

(Continued)

Ran 2005 Not an RCT. Translated personal communication from the author stated “I randomly sampling allocated the patient, did not use any random tool”.

Scott 1999 Not a trial. A review of selected studies of intrapartum support.

Sosa 1980 Strong evidence of selection bias. “A woman was removed from the study if labor was false or prolonged; if fetal distress necessitated an intervention such as oxytocin, caesarean delivery, or forceps”; or if the infant was asphyxiated or ill at birth, etc. “If a woman was removed, her group assignment was inserted at random into the pool of unused assignments. Women were enrolled in the study until there were 20 in the control group and 20 in the experimental group.” The total study sample of 127 mothers includes 95 in the control group and 32 in the experimental group. Thus assignment was not random.

Trueba 2000 Direct contact with investigator revealed that randomization was not used. On arrival at the hospital, women were asked if they wanted to have a doula. If they accepted, a doula was assigned to them. Also support was not continuous throughout active labour for most women, since admission to the labour ward (and assignment of a doula) did not usually occur until 8 cm.

Tryon 1966 Not an RCT. “After a random start, the matched groups were alternately assigned to experimental and control groups.” Women who developed severe complications in labour (number not specified), such as fetal distress, were dropped from the study.

Zhang 1996 Not a trial of continuous one-to-one support. On admission to the labour ward, women received instruction about normal labour, non-pharmacological methods to ease pain, and how to push in second stage, from a team of physicians and nurses. Support was continuous, depending on the women’s needs, but not one-to-one.

EFM: electronic fetal monitoring RCT: randomized controlled trial vs: versus

Characteristics of studies awaiting assessment [ordered by study ID]

Huang 2003

Methods

Participants

Interventions

Outcomes

Notes Communication to author through Chinese Cochrane Centre regarding details of randomization process and infor- mation to allow classification for analysis sub groups.

45Continuous support for women during childbirth (Review)

D A T A A N D A N A L Y S E S

Comparison 1. Continuous support versus usual care - all trials

Outcome or subgroup title No. of

studies

No. of

participants Statistical method Effect size

1 Any analgesia/anaesthesia 13 12169 Risk Ratio (M-H, Random, 95% CI) 0.90 [0.84, 0.97] 2 Regional analgesia/anaesthesia 9 11444 Risk Ratio (M-H, Random, 95% CI) 0.93 [0.88, 0.99] 3 Synthetic oxytocin during labour 14 12506 Risk Ratio (M-H, Random, 95% CI) 0.97 [0.90, 1.04] 4 Labour length 11 5269 Mean Difference (IV, Random, 95% CI) -0.58 [-0.86, -0.30] 5 Spontaneous vaginal birth 18 14005 Risk Ratio (M-H, Random, 95% CI) 1.08 [1.04, 1.12] 6 Instrumental vaginal birth 18 14004 Risk Ratio (M-H, Fixed, 95% CI) 0.90 [0.84, 0.96] 7 Caesarean birth 21 15061 Risk Ratio (M-H, Random, 95% CI) 0.79 [0.67, 0.92] 8 Perineal trauma 4 8120 Risk Ratio (M-H, Random, 95% CI) 0.97 [0.92, 1.01] 9 Low 5-minute Apgar score 12 12401 Risk Ratio (M-H, Fixed, 95% CI) 0.70 [0.50, 0.96] 10 Admission to special care

nursery 7 8897 Risk Ratio (M-H, Random, 95% CI) 0.97 [0.76, 1.25]

11 Prolonged neonatal hospital stay

3 1098 Risk Ratio (M-H, Random, 95% CI) 0.83 [0.42, 1.65]

12 Postpartum report of severe labour pain

4 2456 Risk Ratio (M-H, Random, 95% CI) 1.00 [0.83, 1.21]

13 Negative rating of/negative feelings about birth experience

11 11133 Risk Ratio (M-H, Random, 95% CI) 0.69 [0.59, 0.79]

14 Difficulty mothering 3 6308 Risk Ratio (M-H, Random, 95% CI) 0.60 [0.35, 1.02] 15 Breastfeeding at 1-2 months

postpartum 3 5363 Risk Ratio (M-H, Random, 95% CI) 1.01 [0.94, 1.09]

16 Postpartum depression 1 5567 Risk Ratio (M-H, Fixed, 95% CI) 0.86 [0.73, 1.02] 17 Low postpartum self-esteem 1 652 Risk Ratio (M-H, Fixed, 95% CI) 1.00 [0.77, 1.30]

Comparison 2. Continuous support versus usual care - policy regarding presence of companion

Outcome or subgroup title No. of

studies

No. of

participants Statistical method Effect size

1 Any analgesia/anaesthesia 13 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 1.1 Other support permitted 7 9752 Risk Ratio (IV, Fixed, 95% CI) 0.97 [0.96, 0.99] 1.2 Other support not

permitted 6 2484 Risk Ratio (IV, Fixed, 95% CI) 0.91 [0.85, 0.96]

2 Synthetic oxytocin during labour 14 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 2.1 Other support permitted 5 9495 Risk Ratio (IV, Fixed, 95% CI) 1.04 [0.99, 1.10] 2.2 Other support not

permitted 9 3011 Risk Ratio (IV, Fixed, 95% CI) 0.99 [0.97, 1.01]

3 Spontaneous vaginal birth 18 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 3.1 Other support permitted 9 10889 Risk Ratio (IV, Fixed, 95% CI) 1.03 [1.00, 1.05] 3.2 Other support not

permitted 9 3215 Risk Ratio (IV, Fixed, 95% CI) 1.12 [1.07, 1.16]

46Continuous support for women during childbirth (Review)

4 Caesarean birth 21 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 4.1 Other support permitted 11 11326 Risk Ratio (IV, Fixed, 95% CI) 0.94 [0.85, 1.03]

4.2 Other support not permitted

10 3735 Risk Ratio (IV, Fixed, 95% CI) 0.75 [0.65, 0.87]

5 Admission to special care nursery 7 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 5.1 Other support permitted 2 7328 Risk Ratio (IV, Fixed, 95% CI) 0.99 [0.84, 1.17] 5.2 Other support not

permitted 5 1569 Risk Ratio (IV, Fixed, 95% CI) 0.91 [0.71, 1.17]

6 Postpartum depression 1 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 6.1 Other support permitted 1 5567 Risk Ratio (IV, Fixed, 95% CI) 0.86 [0.73, 1.02] 6.2 Other support not

permitted 0 0 Risk Ratio (IV, Fixed, 95% CI) Not estimable

7 Negative rating of/negative feelings about birth experience

11 Risk Ratio (IV, Fixed, 95% CI) Subtotals only

7.1 Other support permitted 5 8639 Risk Ratio (IV, Fixed, 95% CI) 0.70 [0.62, 0.78] 7.2 Other support not

permitted 6 2539 Risk Ratio (IV, Fixed, 95% CI) 0.62 [0.56, 0.69]

8 Breastfeeding at 1-2 months postpartum

3 Risk Ratio (IV, Fixed, 95% CI) Subtotals only

8.1 Other support permitted 1 4559 Risk Ratio (IV, Fixed, 95% CI) 0.97 [0.92, 1.02]

8.2 Other support not permitted

2 804 Risk Ratio (IV, Fixed, 95% CI) 1.05 [0.98, 1.13]

Comparison 3. Continuous support versus usual care - availability of epidural analgesia

Outcome or subgroup title No. of

studies

No. of

participants Statistical method Effect size

1 Any analgesia/anaesthesia 13 Risk Ratio (IV, Fixed, 95% CI) Subtotals only

1.1 Epidural analgesia routinely available

9 10888 Risk Ratio (IV, Fixed, 95% CI) 0.97 [0.96, 0.98]

1.2 Epidural analgesia not routinely available

4 1348 Risk Ratio (IV, Fixed, 95% CI) 0.83 [0.69, 0.99]

2 Synthetic oxytocin during labour 14 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 2.1 Epidural analgesia

routinely available 8 10568 Risk Ratio (IV, Fixed, 95% CI) 1.00 [0.98, 1.02]

2.2 Epidural analgesia not routinely available

6 1952 Risk Ratio (IV, Fixed, 95% CI) 1.02 [0.93, 1.11]

3 Spontaneous vaginal birth 18 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 3.1 Epidural analgesia

routinely available 13 12672 Risk Ratio (IV, Fixed, 95% CI) 1.04 [1.01, 1.06]

3.2 Epidural analgesia not routinely available

5 1432 Risk Ratio (IV, Fixed, 95% CI) 1.12 [1.06, 1.17]

4 Caesarean birth 21 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 4.1 Epidural analgesia

routinely available 14 13064 Risk Ratio (IV, Fixed, 95% CI) 0.93 [0.86, 1.02]

4.2 Epidural analgesia not routinely available

6 1963 Risk Ratio (IV, Fixed, 95% CI) 0.52 [0.41, 0.67]

47Continuous support for women during childbirth (Review)

4.3 Unknown availability of epidural analgesia

1 34 Risk Ratio (IV, Fixed, 95% CI) 1.4 [0.14, 13.98]

5 Admission to special care nursery 7 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 5.1 Epidural analgesia

routinely available 5 8380 Risk Ratio (IV, Fixed, 95% CI) 0.98 [0.85, 1.13]

5.2 Epidural analgesia not routinely available

2 517 Risk Ratio (IV, Fixed, 95% CI) 0.26 [0.08, 0.88]

6 Postpartum depression 1 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 6.1 Epidural analgesia

routinely available 1 6915 Risk Ratio (IV, Fixed, 95% CI) 0.89 [0.75, 1.05]

6.2 Epidural analgesia not routinely available

0 0 Risk Ratio (IV, Fixed, 95% CI) Not estimable

7 Negative rating of/negative feelings about birth experience

11 Risk Ratio (IV, Fixed, 95% CI) Subtotals only

7.1 Epidural analgesia routinely available

9 10404 Risk Ratio (IV, Fixed, 95% CI) 0.70 [0.64, 0.77]

7.2 Epidural analgesia not routinely available

2 774 Risk Ratio (IV, Fixed, 95% CI) 0.55 [0.48, 0.63]

8 Breastfeeding at 1-2 months postpartum

3 Risk Ratio (IV, Fixed, 95% CI) Subtotals only

8.1 Epidural analgesia routinely available

2 5214 Risk Ratio (IV, Fixed, 95% CI) 0.99 [0.95, 1.03]

8.2 Epidural analgesia not routinely available

1 149 Risk Ratio (IV, Fixed, 95% CI) 1.15 [0.95, 1.40]

Comparison 4. Continuous support versus usual care - policy about routine EFM

Outcome or subgroup title No. of

studies

No. of

participants Statistical method Effect size

1 Any analgesia/anaesthesia 13 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 1.1 Setting had routine EFM 6 8580 Risk Ratio (IV, Fixed, 95% CI) 0.97 [0.96, 0.99] 1.2 Setting did not have

routine EFM 5 2072 Risk Ratio (IV, Fixed, 95% CI) 0.96 [0.90, 1.03]

1.3 Policy about routine EFM not known

2 1579 Risk Ratio (IV, Fixed, 95% CI) 0.89 [0.80, 0.99]

2 Synthetic oxytocin during labour 14 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 2.1 Setting had routine EFM 4 8340 Risk Ratio (IV, Fixed, 95% CI) 1.04 [0.98, 1.11]

2.2 Setting did not have routine EFM

6 1612 Risk Ratio (IV, Fixed, 95% CI) 0.99 [0.96, 1.01]

2.3 Policy about routine EFM not known

4 2568 Risk Ratio (IV, Fixed, 95% CI) 1.02 [0.97, 1.08]

3 Spontaneous vaginal birth 18 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 3.1 Setting had routine EFM 8 9717 Risk Ratio (IV, Fixed, 95% CI) 1.03 [1.01, 1.06] 3.2 Setting did not have

routine EFM 6 1799 Risk Ratio (IV, Fixed, 95% CI) 1.12 [1.06, 1.17]

3.3 Policy about routine EFM not known

4 2561 Risk Ratio (IV, Fixed, 95% CI) 1.07 [1.01, 1.13]

4 Caesarean birth 21 Risk Ratio (IV, Fixed, 95% CI) Subtotals only

48Continuous support for women during childbirth (Review)

4.1 Setting had routine EFM 9 10123 Risk Ratio (IV, Fixed, 95% CI) 0.92 [0.83, 1.01] 4.2 Setting did not have

routine EFM 7 2343 Risk Ratio (IV, Fixed, 95% CI) 0.66 [0.55, 0.80]

4.3 Policy about routine EFM not known

5 2595 Risk Ratio (IV, Fixed, 95% CI) 1.06 [0.84, 1.33]

5 Admission to special care nursery 7 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 5.1 Setting had routine EFM 3 7740 Risk Ratio (IV, Fixed, 95% CI) 0.97 [0.84, 1.11] 5.2 Setting did not have

routine EFM 3 729 Risk Ratio (IV, Fixed, 95% CI) 0.48 [0.21, 1.12]

5.3 Policy about routine EFM not known

1 428 Risk Ratio (IV, Fixed, 95% CI) 1.98 [0.76, 5.18]

6 Postpartum depression 1 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 6.1 Setting had routine EFM 1 6915 Risk Ratio (IV, Fixed, 95% CI) 0.89 [0.75, 1.05] 6.2 Setting did not have

routine EFM 0 0 Risk Ratio (IV, Fixed, 95% CI) Not estimable

7 Negative rating of /negative views about birth experience

11 Risk Ratio (IV, Fixed, 95% CI) Subtotals only

7.1 Setting had routine EFM 4 7467 Risk Ratio (IV, Fixed, 95% CI) 0.67 [0.60, 0.76] 7.2 Setting did not have

routine EFM 4 1710 Risk Ratio (IV, Fixed, 95% CI) 0.60 [0.53, 0.68]

7.3 Policy about routine EFM not known

3 1977 Risk Ratio (IV, Fixed, 95% CI) 0.84 [0.65, 1.08]

8 Breastfeeding at 1-2 months postpartum

3 Risk Ratio (IV, Fixed, 95% CI) Subtotals only

8.1 Setting had routine EFM 1 4559 Risk Ratio (IV, Fixed, 95% CI) 0.97 [0.92, 1.02] 8.2 Setting did not have

routine EFM 2 804 Risk Ratio (IV, Fixed, 95% CI) 1.05 [0.98, 1.13]

Comparison 5. Continuous support versus usual care - variations in provider characteristics

Outcome or subgroup title No. of

studies

No. of

participants Statistical method Effect size

1 Any analgesia/anaesthesia 13 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 1.1 Support people were

hospital staff 6 9152 Risk Ratio (IV, Fixed, 95% CI) 0.97 [0.96, 0.99]

1.2 Support people were not hospital staff and not chosen by woman

4 1790 Risk Ratio (IV, Fixed, 95% CI) 0.91 [0.86, 0.97]

1.3 Support people were not hospital staff and were chosen by woman

3 1294 Risk Ratio (IV, Fixed, 95% CI) 0.94 [0.88, 1.00]

2 Synthetic oxytocin during labour 14 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 2.1 Support people were

hospital staff 6 9561 Risk Ratio (IV, Fixed, 95% CI) 1.06 [1.01, 1.11]

2.2 Support people were not hospital staff and not chosen by woman

3 1018 Risk Ratio (IV, Fixed, 95% CI) 0.69 [0.50, 0.94]

49Continuous support for women during childbirth (Review)

2.3 Support people were not hospital staff and were chosen by woman

5 1927 Risk Ratio (IV, Fixed, 95% CI) 0.99 [0.96, 1.01]

3 Spontaneous vaginal birth 18 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 3.1 Support people were

hospital staff 9 10813 Risk Ratio (IV, Fixed, 95% CI) 1.03 [1.01, 1.06]

3.2 Support people were not hospital staff and not chosen by woman

5 1935 Risk Ratio (IV, Fixed, 95% CI) 1.12 [1.07, 1.17]

3.3 Support people were not hospital staff and were chosen by woman

4 1356 Risk Ratio (IV, Fixed, 95% CI) 1.07 [0.99, 1.15]

4 Caesarean birth 21 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 4.1 Support people were

hospital staff 9 10786 Risk Ratio (IV, Fixed, 95% CI) 0.95 [0.85, 1.05]

4.2 Support people were not hospital staff and not chosen by woman

7 2330 Risk Ratio (IV, Fixed, 95% CI) 0.72 [0.60, 0.86]

4.3 Support people were not hospital staff and were chosen by woman

5 1945 Risk Ratio (IV, Fixed, 95% CI) 0.84 [0.69, 1.03]

5 Admission to special care nursery 7 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 5.1 Support people were

hospital staff 3 7428 Risk Ratio (IV, Fixed, 95% CI) 0.99 [0.84, 1.17]

5.2 Support people were not hospital staff and not chosen by woman

2 829 Risk Ratio (IV, Fixed, 95% CI) 0.86 [0.66, 1.12]

5.3 Support people were not hospital staff and were chosen by woman

2 640 Risk Ratio (IV, Fixed, 95% CI) 1.40 [0.67, 2.93]

6 Postpartum depression 1 Risk Ratio (IV, Fixed, 95% CI) Subtotals only 6.1 Support people were

hospital staff 1 5567 Risk Ratio (IV, Fixed, 95% CI) 0.86 [0.73, 1.02]

6.2 Support people were not hospital staff and not chosen by woman

0 0 Risk Ratio (IV, Fixed, 95% CI) Not estimable

6.3 Support people were not hospital staff and were chosen by woman

0 0 Risk Ratio (IV, Fixed, 95% CI) Not estimable

7 Negative rating of/negative feelings about birth experience

11 Risk Ratio (IV, Fixed, 95% CI) Subtotals only

7.1 Support people were hospital staff

4 8145 Risk Ratio (IV, Fixed, 95% CI) 0.87 [0.73, 1.03]

7.2 Support people were not hospital staff and not chosen by woman

3 1325 Risk Ratio (IV, Fixed, 95% CI) 0.66 [0.57, 0.77]

7.3 Support people were not hospital staff and were chosen by woman

4 1708 Risk Ratio (IV, Fixed, 95% CI) 0.57 [0.51, 0.64]

8 Breastfeeding at 1-2 months postpartum

3 Risk Ratio (IV, Fixed, 95% CI) Subtotals only

50Continuous support for women during childbirth (Review)

8.1 Support people were hospital staff

1 4559 Risk Ratio (IV, Fixed, 95% CI) 0.97 [0.92, 1.02]

8.2 Support people were not hospital staff and not chosen by woman

2 804 Risk Ratio (IV, Fixed, 95% CI) 1.05 [0.98, 1.13]

8.3 Support people were not hospital staff and were chosen by woman

0 0 Risk Ratio (IV, Fixed, 95% CI) Not estimable

Analysis 1.1. Comparison 1 Continuous support versus usual care - all trials, Outcome 1 Any

analgesia/anaesthesia.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 1 Any analgesia/anaesthesia

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

Morhason-Bello 2009 84/293 89/292 5.2 % 0.94 [ 0.73, 1.21 ]

Campbell 2006 247/291 260/295 14.0 % 0.96 [ 0.90, 1.03 ]

Hodnett 2002 3077/3454 3159/3461 15.8 % 0.98 [ 0.96, 0.99 ]

Madi 1999 28/53 41/56 4.0 % 0.72 [ 0.53, 0.97 ]

Langer 1998 295/361 302/363 13.8 % 0.98 [ 0.92, 1.05 ]

Gagnon 1997 141/209 142/204 10.1 % 0.97 [ 0.85, 1.10 ]

Breart - Belgium 1992 55/133 62/128 4.6 % 0.85 [ 0.65, 1.12 ]

Breart - France 1992 281/652 319/666 10.8 % 0.90 [ 0.80, 1.01 ]

Hofmeyr 1991 52/92 56/97 5.2 % 0.98 [ 0.76, 1.25 ]

Kennell 1991 93/212 150/200 8.0 % 0.58 [ 0.49, 0.69 ]

Hemminki 1990a 25/41 23/38 3.1 % 1.01 [ 0.71, 1.44 ]

Hemminki 1990b 45/81 52/80 5.1 % 0.85 [ 0.66, 1.10 ]

Klaus 1986 2/168 10/249 0.2 % 0.30 [ 0.07, 1.34 ]

Total (95% CI) 6040 6129 100.0 % 0.90 [ 0.84, 0.97 ]

Total events: 4425 (Continuous support), 4665 (Usual care)

Heterogeneity: Tau2 = 0.01; Chi2 = 50.70, df = 12 (P<0.00001); I2 =76%

Test for overall effect: Z = 2.95 (P = 0.0032)

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

51Continuous support for women during childbirth (Review)

Analysis 1.2. Comparison 1 Continuous support versus usual care - all trials, Outcome 2 Regional

analgesia/anaesthesia.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 2 Regional analgesia/anaesthesia

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

McGrath 2008 145/224 149/196 10.3 % 0.85 [ 0.75, 0.96 ]

Campbell 2006 247/291 260/295 14.6 % 0.96 [ 0.90, 1.03 ]

Hodnett 2002 2349/3454 2436/3461 16.6 % 0.97 [ 0.94, 1.00 ]

Torres 1999 202/217 195/218 15.0 % 1.04 [ 0.98, 1.10 ]

Langer 1998 295/335 302/346 15.2 % 1.01 [ 0.95, 1.07 ]

Gagnon 1997 139/209 142/204 9.8 % 0.96 [ 0.84, 1.09 ]

Breart - Belgium 1992 55/133 62/131 4.1 % 0.87 [ 0.67, 1.15 ]

Breart - France 1992 281/652 319/666 10.7 % 0.90 [ 0.80, 1.01 ]

Kennell 1991 47/212 94/200 3.7 % 0.47 [ 0.35, 0.63 ]

Total (95% CI) 5727 5717 100.0 % 0.93 [ 0.88, 0.99 ]

Total events: 3760 (Continuous support), 3959 (Usual care)

Heterogeneity: Tau2 = 0.01; Chi2 = 41.66, df = 8 (P<0.00001); I2 =81%

Test for overall effect: Z = 2.16 (P = 0.031)

0.5 0.7 1 1.5 2

Favours support Favours usual care

52Continuous support for women during childbirth (Review)

Analysis 1.3. Comparison 1 Continuous support versus usual care - all trials, Outcome 3 Synthetic oxytocin

during labour.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 3 Synthetic oxytocin during labour

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

Kashanian 2010 11/50 19/50 1.1 % 0.58 [ 0.31, 1.09 ]

Morhason-Bello 2009 51/293 56/292 3.3 % 0.91 [ 0.64, 1.28 ]

Bruggemann 2007 104/105 107/107 17.2 % 0.99 [ 0.96, 1.02 ]

Campbell 2006 133/291 144/295 8.4 % 0.94 [ 0.79, 1.11 ]

Hodnett 2002 1040/3454 942/3461 14.6 % 1.11 [ 1.03, 1.19 ]

Madi 1999 7/53 17/56 0.7 % 0.44 [ 0.20, 0.96 ]

Torres 1999 167/217 172/218 12.9 % 0.98 [ 0.88, 1.08 ]

Gagnon 1997 82/209 96/204 6.2 % 0.83 [ 0.67, 1.04 ]

Breart - Belgium 1992 55/132 64/129 4.9 % 0.84 [ 0.64, 1.10 ]

Breart - France 1992 383/654 371/666 13.3 % 1.05 [ 0.96, 1.15 ]

Breart - Greece 1992 224/287 193/265 13.1 % 1.07 [ 0.97, 1.18 ]

Hofmeyr 1991 16/92 17/97 1.2 % 0.99 [ 0.53, 1.85 ]

Kennell 1991 36/212 46/200 2.6 % 0.74 [ 0.50, 1.09 ]

Klaus 1986 4/168 37/249 0.5 % 0.16 [ 0.06, 0.44 ]

Total (95% CI) 6217 6289 100.0 % 0.97 [ 0.90, 1.04 ]

Total events: 2313 (Continuous support), 2281 (Usual care)

Heterogeneity: Tau2 = 0.01; Chi2 = 39.59, df = 13 (P = 0.00016); I2 =67%

Test for overall effect: Z = 0.89 (P = 0.37)

0.2 0.5 1 2 5

Favours support Favours usual care

53Continuous support for women during childbirth (Review)

Analysis 1.4. Comparison 1 Continuous support versus usual care - all trials, Outcome 4 Labour length.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 4 Labour length

Study or subgroup Continuous support Usual care Mean Difference Weight Mean Difference

N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Morhason-Bello 2009 293 4.7 (1.7) 292 5.3 (1.7) 19.0 % -0.60 [ -0.88, -0.32 ]

Campbell 2006 291 10.4 (4.3) 295 11.7 (4.8) 8.8 % -1.30 [ -2.04, -0.56 ]

Gagnon 1997 209 9.1 (4.1) 204 9.4 (4.7) 7.3 % -0.30 [ -1.15, 0.55 ]

Breart - Belgium 1992 133 6.27 (5.37) 129 6.8 (4.07) 4.7 % -0.53 [ -1.68, 0.62 ]

Breart - France 1992 654 6.77 (2.57) 666 7.07 (2.68) 18.8 % -0.30 [ -0.58, -0.02 ]

Breart - Greece 1992 287 6.67 (3.75) 265 6.33 (3.92) 10.4 % 0.34 [ -0.30, 0.98 ]

Kennell 1991 212 7.4 (3.8) 200 8.4 (4.2) 8.3 % -1.00 [ -1.77, -0.23 ]

Hofmeyr 1991 92 9.6 (3.93) 97 10.2 (4.92) 4.0 % -0.60 [ -1.87, 0.67 ]

Langer 1998 361 4.56 (3.47) 363 5.58 (3.47) 13.2 % -1.02 [ -1.53, -0.51 ]

Hemminki 1990a 34 8.3 (6.2) 31 10 (6.8) 0.7 % -1.70 [ -4.87, 1.47 ]

Hemminki 1990b 81 5.1 (3.8) 80 5.7 (3.7) 4.6 % -0.60 [ -1.76, 0.56 ]

Total (95% CI) 2647 2622 100.0 % -0.58 [ -0.86, -0.30 ]

Heterogeneity: Tau2 = 0.09; Chi2 = 19.89, df = 10 (P = 0.03); I2 =50%

Test for overall effect: Z = 4.08 (P = 0.000045)

-4 -2 0 2 4

Favours support Favours usual care

54Continuous support for women during childbirth (Review)

Analysis 1.5. Comparison 1 Continuous support versus usual care - all trials, Outcome 5 Spontaneous

vaginal birth.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 5 Spontaneous vaginal birth

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

Kashanian 2010 46/50 38/50 3.3 % 1.21 [ 1.02, 1.44 ]

Bruggemann 2007 41/105 38/107 1.0 % 1.10 [ 0.78, 1.56 ]

Campbell 2006 223/291 220/295 7.5 % 1.03 [ 0.94, 1.13 ]

Hodnett 2002 2481/3454 2463/3461 13.3 % 1.01 [ 0.98, 1.04 ]

Dickinson 2002 280/499 239/493 5.6 % 1.16 [ 1.03, 1.30 ]

Madi 1999 48/53 40/56 3.0 % 1.27 [ 1.05, 1.53 ]

Torres 1999 110/217 101/218 2.8 % 1.09 [ 0.90, 1.33 ]

Langer 1998 260/357 247/357 7.4 % 1.05 [ 0.96, 1.16 ]

Gagnon 1997 132/209 127/204 4.2 % 1.01 [ 0.87, 1.18 ]

Breart - Belgium 1992 97/133 85/129 3.7 % 1.11 [ 0.94, 1.30 ]

Breart - France 1992 451/654 425/665 8.8 % 1.08 [ 1.00, 1.17 ]

Breart - Greece 1992 202/282 183/263 6.3 % 1.03 [ 0.92, 1.15 ]

Hofmeyr 1991 74/92 76/97 4.4 % 1.03 [ 0.89, 1.19 ]

Kennell 1991 179/212 137/200 6.2 % 1.23 [ 1.10, 1.38 ]

Hemminki 1990a 38/41 34/38 4.6 % 1.04 [ 0.90, 1.19 ]

Hemminki 1990b 76/81 72/80 7.5 % 1.04 [ 0.95, 1.14 ]

Hodnett 1989 47/72 42/73 1.7 % 1.13 [ 0.88, 1.47 ]

Klaus 1986 154/168 196/249 8.6 % 1.16 [ 1.08, 1.26 ]

Total (95% CI) 6970 7035 100.0 % 1.08 [ 1.04, 1.12 ]

Total events: 4939 (Continuous support), 4763 (Usual care)

Heterogeneity: Tau2 = 0.00; Chi2 = 32.63, df = 17 (P = 0.01); I2 =48%

Test for overall effect: Z = 4.29 (P = 0.000018)

0.5 0.7 1 1.5 2

Favours usual care Favours support

55Continuous support for women during childbirth (Review)

Analysis 1.6. Comparison 1 Continuous support versus usual care - all trials, Outcome 6 Instrumental

vaginal birth.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 6 Instrumental vaginal birth

Study or subgroup Continuous support Usual care Risk Ratio Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

Kashanian 2010 0/50 0/50 0.0 [ 0.0, 0.0 ]

Bruggemann 2007 53/105 57/107 0.95 [ 0.73, 1.23 ]

Campbell 2006 13/291 22/295 0.60 [ 0.31, 1.17 ]

Hodnett 2002 541/3454 561/3461 0.97 [ 0.87, 1.08 ]

Dickinson 2002 148/499 169/493 0.87 [ 0.72, 1.04 ]

Madi 1999 2/53 9/56 0.23 [ 0.05, 1.04 ]

Torres 1999 163/217 171/218 0.96 [ 0.86, 1.06 ]

Langer 1998 12/357 12/356 1.00 [ 0.45, 2.19 ]

Gagnon 1997 48/209 44/204 1.06 [ 0.74, 1.53 ]

Breart - Belgium 1992 31/133 39/129 0.77 [ 0.51, 1.16 ]

Breart - France 1992 163/654 204/665 0.81 [ 0.68, 0.97 ]

Breart - Greece 1992 50/282 46/263 1.01 [ 0.70, 1.46 ]

Hofmeyr 1991 7/92 7/97 1.05 [ 0.38, 2.89 ]

Kennell 1991 16/212 37/200 0.41 [ 0.23, 0.71 ]

Hemminki 1990a 3/41 1/38 2.78 [ 0.30, 25.59 ]

Hemminki 1990b 3/81 5/80 0.59 [ 0.15, 2.40 ]

Hodnett 1989 13/72 18/73 0.73 [ 0.39, 1.38 ]

Klaus 1986 2/168 7/249 0.42 [ 0.09, 2.01 ]

Total (95% CI) 6970 7034 0.90 [ 0.84, 0.96 ]

Total events: 1268 (Continuous support), 1409 (Usual care)

Heterogeneity: Chi2 = 21.72, df = 16 (P = 0.15); I2 =26%

Test for overall effect: Z = 3.23 (P = 0.0012)

0.05 0.2 1 5 20

Favours support Favours usual care

56Continuous support for women during childbirth (Review)

Analysis 1.7. Comparison 1 Continuous support versus usual care - all trials, Outcome 7 Caesarean birth.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 7 Caesarean birth

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

Kashanian 2010 4/50 12/50 1.9 % 0.33 [ 0.12, 0.96 ]

Morhason-Bello 2009 27/305 68/298 6.5 % 0.39 [ 0.26, 0.59 ]

McGrath 2008 30/224 49/196 6.6 % 0.54 [ 0.35, 0.81 ]

Bruggemann 2007 11/105 12/107 3.1 % 0.93 [ 0.43, 2.02 ]

Campbell 2006 55/291 53/295 7.7 % 1.05 [ 0.75, 1.48 ]

Hodnett 2002 432/3454 437/3461 11.2 % 0.99 [ 0.87, 1.12 ]

Dickinson 2002 71/499 85/493 8.5 % 0.83 [ 0.62, 1.10 ]

Madi 1999 3/53 7/56 1.3 % 0.45 [ 0.12, 1.66 ]

Torres 1999 54/217 46/218 7.6 % 1.18 [ 0.83, 1.67 ]

Langer 1998 85/357 97/356 9.2 % 0.87 [ 0.68, 1.12 ]

Gagnon 1997 29/209 33/204 5.9 % 0.86 [ 0.54, 1.36 ]

Breart - Belgium 1992 5/133 5/129 1.5 % 0.97 [ 0.29, 3.27 ]

Breart - France 1992 40/654 36/665 6.2 % 1.13 [ 0.73, 1.75 ]

Breart - Greece 1992 30/282 34/263 5.9 % 0.82 [ 0.52, 1.31 ]

Hofmeyr 1991 11/92 14/97 3.3 % 0.83 [ 0.40, 1.73 ]

Kennell 1991 17/212 26/200 4.6 % 0.62 [ 0.35, 1.10 ]

Hemminki 1990a 0/41 3/38 0.3 % 0.13 [ 0.01, 2.49 ]

Hemminki 1990b 2/81 3/80 0.7 % 0.66 [ 0.11, 3.84 ]

Hodnett 1989 12/72 13/73 3.4 % 0.94 [ 0.46, 1.91 ]

Cogan 1988 2/20 1/14 0.4 % 1.40 [ 0.14, 13.98 ]

Klaus 1986 12/168 46/249 4.3 % 0.39 [ 0.21, 0.71 ]

Total (95% CI) 7519 7542 100.0 % 0.79 [ 0.67, 0.92 ]

Total events: 932 (Continuous support), 1080 (Usual care)

Heterogeneity: Tau2 = 0.05; Chi2 = 44.11, df = 20 (P = 0.001); I2 =55%

Test for overall effect: Z = 3.01 (P = 0.0026)

0.05 0.2 1 5 20

Favours support Favours usual care

57Continuous support for women during childbirth (Review)

Analysis 1.8. Comparison 1 Continuous support versus usual care - all trials, Outcome 8 Perineal trauma.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 8 Perineal trauma

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

Bruggemann 2007 94/105 95/107 16.1 % 1.01 [ 0.92, 1.11 ]

Hodnett 2002 1828/3454 1860/3461 37.0 % 0.98 [ 0.94, 1.03 ]

Campbell 2006 249/291 275/295 30.0 % 0.92 [ 0.87, 0.97 ]

Gagnon 1997 168/207 166/200 16.9 % 0.98 [ 0.89, 1.07 ]

Total (95% CI) 4057 4063 100.0 % 0.97 [ 0.92, 1.01 ]

Total events: 2339 (Continuous support), 2396 (Usual care)

Heterogeneity: Tau2 = 0.00; Chi2 = 5.33, df = 3 (P = 0.15); I2 =44%

Test for overall effect: Z = 1.50 (P = 0.13)

0.5 0.7 1 1.5 2

Favours support Favours usual care

58Continuous support for women during childbirth (Review)

Analysis 1.9. Comparison 1 Continuous support versus usual care - all trials, Outcome 9 Low 5-minute

Apgar score.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 9 Low 5-minute Apgar score

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

Kashanian 2010 0/50 1/50 1.7 % 0.33 [ 0.01, 7.99 ]

McGrath 2008 4/224 6/196 7.3 % 0.58 [ 0.17, 2.04 ]

Bruggemann 2007 3/105 2/107 2.3 % 1.53 [ 0.26, 8.96 ]

Campbell 2006 1/291 9/295 10.2 % 0.11 [ 0.01, 0.88 ]

Hodnett 2002 30/3454 25/3461 28.4 % 1.20 [ 0.71, 2.04 ]

Dickinson 2002 4/499 8/493 9.2 % 0.49 [ 0.15, 1.63 ]

Torres 1999 1/217 5/218 5.7 % 0.20 [ 0.02, 1.71 ]

Breart - Belgium 1992 3/132 4/128 4.6 % 0.73 [ 0.17, 3.19 ]

Breart - France 1992 4/651 11/664 12.4 % 0.37 [ 0.12, 1.16 ]

Breart - Greece 1992 6/295 8/274 9.4 % 0.70 [ 0.24, 1.98 ]

Hofmeyr 1991 4/89 6/96 6.6 % 0.72 [ 0.21, 2.46 ]

Kennell 1991 1/212 2/200 2.3 % 0.47 [ 0.04, 5.16 ]

Total (95% CI) 6219 6182 100.0 % 0.70 [ 0.50, 0.96 ]

Total events: 61 (Continuous support), 87 (Usual care)

Heterogeneity: Chi2 = 11.05, df = 11 (P = 0.44); I2 =0%

Test for overall effect: Z = 2.20 (P = 0.028)

0.02 0.1 1 10 50

Favours support Favours usual care

59Continuous support for women during childbirth (Review)

Analysis 1.10. Comparison 1 Continuous support versus usual care - all trials, Outcome 10 Admission to

special care nursery.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 10 Admission to special care nursery

Study or subgroup Continuous support Usual care Risk Ratio Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

Kashanian 2010 0/50 0/50 0.0 [ 0.0, 0.0 ]

Bruggemann 2007 5/105 6/107 0.85 [ 0.27, 2.70 ]

Hodnett 2002 246/3454 254/3461 0.97 [ 0.82, 1.15 ]

Torres 1999 12/215 6/213 1.98 [ 0.76, 5.18 ]

Gagnon 1997 15/209 10/204 1.46 [ 0.67, 3.18 ]

Kennell 1991 69/212 71/200 0.92 [ 0.70, 1.20 ]

Klaus 1986 3/168 17/249 0.26 [ 0.08, 0.88 ]

Total (95% CI) 4413 4484 0.97 [ 0.76, 1.25 ]

Total events: 350 (Continuous support), 364 (Usual care)

Heterogeneity: Tau2 = 0.03; Chi2 = 7.91, df = 5 (P = 0.16); I2 =37%

Test for overall effect: Z = 0.22 (P = 0.82)

0.05 0.2 1 5 20

Favours support Favours usual care

60Continuous support for women during childbirth (Review)

Analysis 1.11. Comparison 1 Continuous support versus usual care - all trials, Outcome 11 Prolonged

neonatal hospital stay.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 11 Prolonged neonatal hospital stay

Study or subgroup Continuous support Usual care Risk Ratio Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

Kashanian 2010 0/50 0/50 0.0 [ 0.0, 0.0 ]

Campbell 2006 17/291 14/295 1.23 [ 0.62, 2.45 ]

Kennell 1991 22/212 34/200 0.61 [ 0.37, 1.01 ]

Total (95% CI) 553 545 0.83 [ 0.42, 1.65 ]

Total events: 39 (Continuous support), 48 (Usual care)

Heterogeneity: Tau2 = 0.15; Chi2 = 2.61, df = 1 (P = 0.11); I2 =62%

Test for overall effect: Z = 0.53 (P = 0.60)

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

Analysis 1.12. Comparison 1 Continuous support versus usual care - all trials, Outcome 12 Postpartum

report of severe labour pain.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 12 Postpartum report of severe labour pain

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

Langer 1998 261/356 248/352 31.1 % 1.04 [ 0.95, 1.14 ]

Breart - Belgium 1992 61/119 53/121 20.2 % 1.17 [ 0.90, 1.53 ]

Breart - France 1992 157/656 139/664 24.4 % 1.14 [ 0.93, 1.40 ]

Hofmeyr 1991 53/92 76/96 24.3 % 0.73 [ 0.59, 0.89 ]

Total (95% CI) 1223 1233 100.0 % 1.00 [ 0.83, 1.21 ]

Total events: 532 (Continuous support), 516 (Usual care)

Heterogeneity: Tau2 = 0.03; Chi2 = 13.35, df = 3 (P = 0.004); I2 =78%

Test for overall effect: Z = 0.00 (P = 1.0)

0.5 0.7 1 1.5 2

Favours support Favours usual care

61Continuous support for women during childbirth (Review)

Analysis 1.13. Comparison 1 Continuous support versus usual care - all trials, Outcome 13 Negative rating

of/negative feelings about birth experience.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 13 Negative rating of/negative feelings about birth experience

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

Morhason-Bello 2009 108/293 196/292 13.4 % 0.55 [ 0.46, 0.65 ]

Bruggemann 2007 7/105 17/107 2.5 % 0.42 [ 0.18, 0.97 ]

Campbell 2006 95/229 197/265 13.4 % 0.56 [ 0.47, 0.66 ]

Hodnett 2002 96/2818 117/2751 10.5 % 0.80 [ 0.61, 1.04 ]

Dickinson 2002 75/499 74/493 9.7 % 1.00 [ 0.74, 1.35 ]

Torres 1999 35/206 43/211 7.2 % 0.83 [ 0.56, 1.25 ]

Langer 1998 98/357 129/353 11.9 % 0.75 [ 0.60, 0.93 ]

Breart - Belgium 1992 24/119 30/121 5.9 % 0.81 [ 0.51, 1.31 ]

Breart - France 1992 30/656 35/664 5.9 % 0.87 [ 0.54, 1.40 ]

Hofmeyr 1991 38/92 73/96 10.4 % 0.54 [ 0.42, 0.71 ]

Kennell 1991 47/209 71/197 9.2 % 0.62 [ 0.46, 0.85 ]

Total (95% CI) 5583 5550 100.0 % 0.69 [ 0.59, 0.79 ]

Total events: 653 (Continuous support), 982 (Usual care)

Heterogeneity: Tau2 = 0.03; Chi2 = 26.81, df = 10 (P = 0.003); I2 =63%

Test for overall effect: Z = 5.16 (P < 0.00001)

0.2 0.5 1 2 5

Favours support Favours usual care

62Continuous support for women during childbirth (Review)

Analysis 1.14. Comparison 1 Continuous support versus usual care - all trials, Outcome 14 Difficulty

mothering.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 14 Difficulty mothering

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

Campbell 2006 11/292 38/265 24.7 % 0.26 [ 0.14, 0.50 ]

Hodnett 2002 873/2836 853/2765 38.7 % 1.00 [ 0.92, 1.08 ]

Hofmeyr 1991 41/75 67/75 36.6 % 0.61 [ 0.49, 0.76 ]

Total (95% CI) 3203 3105 100.0 % 0.60 [ 0.35, 1.02 ]

Total events: 925 (Continuous support), 958 (Usual care)

Heterogeneity: Tau2 = 0.19; Chi2 = 31.58, df = 2 (P<0.00001); I2 =94%

Test for overall effect: Z = 1.88 (P = 0.060)

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

Analysis 1.15. Comparison 1 Continuous support versus usual care - all trials, Outcome 15 Breastfeeding at

1-2 months postpartum.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 15 Breastfeeding at 1-2 months postpartum

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Random,95% CI M-H,Random,95% CI

Hodnett 2002 1312/2339 1283/2220 50.8 % 0.97 [ 0.92, 1.02 ]

Hofmeyr 1991 58/74 51/75 11.9 % 1.15 [ 0.95, 1.40 ]

Langer 1998 266/334 247/321 37.3 % 1.04 [ 0.95, 1.12 ]

Total (95% CI) 2747 2616 100.0 % 1.01 [ 0.94, 1.09 ]

Total events: 1636 (Continuous support), 1581 (Usual care)

Heterogeneity: Tau2 = 0.00; Chi2 = 4.18, df = 2 (P = 0.12); I2 =52%

Test for overall effect: Z = 0.38 (P = 0.70)

0.5 0.7 1 1.5 2

Favours support Favours usual care

63Continuous support for women during childbirth (Review)

Analysis 1.16. Comparison 1 Continuous support versus usual care - all trials, Outcome 16 Postpartum

depression.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 16 Postpartum depression

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

Hodnett 2002 245/2816 277/2751 100.0 % 0.86 [ 0.73, 1.02 ]

Total (95% CI) 2816 2751 100.0 % 0.86 [ 0.73, 1.02 ]

Total events: 245 (Continuous support), 277 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 1.75 (P = 0.080)

0.05 0.2 1 5 20

Favours support Favours usual care

Analysis 1.17. Comparison 1 Continuous support versus usual care - all trials, Outcome 17 Low postpartum

self-esteem.

Review: Continuous support for women during childbirth

Comparison: 1 Continuous support versus usual care - all trials

Outcome: 17 Low postpartum self-esteem

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

Langer 1998 85/336 80/316 100.0 % 1.00 [ 0.77, 1.30 ]

Total (95% CI) 336 316 100.0 % 1.00 [ 0.77, 1.30 ]

Total events: 85 (Continuous support), 80 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 0.01 (P = 1.0)

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

64Continuous support for women during childbirth (Review)

Analysis 2.1. Comparison 2 Continuous support versus usual care - policy regarding presence of companion,

Outcome 1 Any analgesia/anaesthesia.

Review: Continuous support for women during childbirth

Comparison: 2 Continuous support versus usual care - policy regarding presence of companion

Outcome: 1 Any analgesia/anaesthesia

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Other support permitted

Campbell 2006 247/300 260/300 4.7 % 0.95 [ 0.89, 1.02 ]

Hodnett 2002 3077/3454 3159/3461 91.6 % 0.98 [ 0.96, 0.99 ]

Gagnon 1997 141/209 142/204 1.3 % 0.97 [ 0.85, 1.10 ]

Breart - Belgium 1992 55/133 62/131 0.3 % 0.87 [ 0.67, 1.15 ]

Breart - France 1992 281/656 319/664 1.6 % 0.89 [ 0.79, 1.00 ]

Hemminki 1990a 25/41 23/38 0.2 % 1.01 [ 0.71, 1.44 ]

Hemminki 1990b 45/81 52/80 0.3 % 0.85 [ 0.66, 1.10 ]

Subtotal (95% CI) 4874 4878 100.0 % 0.97 [ 0.96, 0.99 ]

Total events: 3871 (Continuous support), 4017 (Usual care)

Heterogeneity: Chi2 = 4.35, df = 6 (P = 0.63); I2 =0.0%

Test for overall effect: Z = 3.66 (P = 0.00025)

2 Other support not permitted

Morhason-Bello 2009 84/293 89/292 5.6 % 0.94 [ 0.73, 1.21 ]

Madi 1999 28/53 41/56 3.9 % 0.72 [ 0.53, 0.97 ]

Langer 1998 295/361 302/363 77.8 % 0.98 [ 0.92, 1.05 ]

Hofmeyr 1991 11/92 15/97 0.7 % 0.77 [ 0.37, 1.59 ]

Kennell 1991 93/212 150/200 11.9 % 0.58 [ 0.49, 0.69 ]

Klaus 1986 2/186 10/279 0.2 % 0.30 [ 0.07, 1.35 ]

Subtotal (95% CI) 1197 1287 100.0 % 0.91 [ 0.85, 0.96 ]

Total events: 513 (Continuous support), 607 (Usual care)

Heterogeneity: Chi2 = 34.96, df = 5 (P<0.00001); I2 =86%

Test for overall effect: Z = 3.22 (P = 0.0013)

Test for subgroup differences: Chi2 = 4.98, df = 1 (P = 0.03), I2 =80%

0.2 0.5 1 2 5

Favours support Favours usual care

65Continuous support for women during childbirth (Review)

Analysis 2.2. Comparison 2 Continuous support versus usual care - policy regarding presence of companion,

Outcome 2 Synthetic oxytocin during labour.

Review: Continuous support for women during childbirth

Comparison: 2 Continuous support versus usual care - policy regarding presence of companion

Outcome: 2 Synthetic oxytocin during labour

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Other support permitted

Campbell 2006 133/291 144/295 9.4 % 0.94 [ 0.79, 1.11 ]

Hodnett 2002 1040/3454 942/3461 49.7 % 1.11 [ 1.03, 1.19 ]

Gagnon 1997 82/209 96/204 5.5 % 0.83 [ 0.67, 1.04 ]

Breart - Belgium 1992 55/132 64/129 3.9 % 0.84 [ 0.64, 1.10 ]

Breart - France 1992 383/654 371/666 31.5 % 1.05 [ 0.96, 1.15 ]

Subtotal (95% CI) 4740 4755 100.0 % 1.04 [ 0.99, 1.10 ]

Total events: 1693 (Continuous support), 1617 (Usual care)

Heterogeneity: Chi2 = 10.37, df = 4 (P = 0.03); I2 =61%

Test for overall effect: Z = 1.60 (P = 0.11)

2 Other support not permitted

Kashanian 2010 11/50 19/50 0.1 % 0.58 [ 0.31, 1.09 ]

Morhason-Bello 2009 51/293 56/292 0.5 % 0.91 [ 0.64, 1.28 ]

Bruggemann 2007 104/105 107/107 86.3 % 0.99 [ 0.96, 1.02 ]

Madi 1999 7/53 17/56 0.1 % 0.44 [ 0.20, 0.96 ]

Torres 1999 167/217 172/218 5.9 % 0.98 [ 0.88, 1.08 ]

Breart - Greece 1992 224/287 193/265 6.5 % 1.07 [ 0.97, 1.18 ]

Hofmeyr 1991 16/92 17/97 0.2 % 0.99 [ 0.53, 1.85 ]

Kennell 1991 36/212 46/200 0.4 % 0.74 [ 0.50, 1.09 ]

Klaus 1986 4/168 37/249 0.1 % 0.16 [ 0.06, 0.44 ]

Subtotal (95% CI) 1477 1534 100.0 % 0.99 [ 0.97, 1.01 ]

Total events: 620 (Continuous support), 664 (Usual care)

Heterogeneity: Chi2 = 24.42, df = 8 (P = 0.002); I2 =67%

Test for overall effect: Z = 0.78 (P = 0.44)

Test for subgroup differences: Chi2 = 3.16, df = 1 (P = 0.08), I2 =68%

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

66Continuous support for women during childbirth (Review)

Analysis 2.3. Comparison 2 Continuous support versus usual care - policy regarding presence of companion,

Outcome 3 Spontaneous vaginal birth.

Review: Continuous support for women during childbirth

Comparison: 2 Continuous support versus usual care - policy regarding presence of companion

Outcome: 3 Spontaneous vaginal birth

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Other support permitted

Campbell 2006 223/300 220/300 6.3 % 1.01 [ 0.92, 1.11 ]

Hodnett 2002 2481/3454 2463/3461 64.6 % 1.01 [ 0.98, 1.04 ]

Dickinson 2002 280/499 239/493 4.0 % 1.16 [ 1.03, 1.30 ]

Gagnon 1997 132/209 127/204 2.6 % 1.01 [ 0.87, 1.18 ]

Breart - Belgium 1992 97/133 87/131 2.2 % 1.10 [ 0.94, 1.29 ]

Breart - France 1992 453/656 424/664 9.7 % 1.08 [ 1.00, 1.17 ]

Hemminki 1990a 38/41 34/38 3.0 % 1.04 [ 0.90, 1.19 ]

Hemminki 1990b 76/81 72/80 6.8 % 1.04 [ 0.95, 1.14 ]

Hodnett 1989 47/72 42/73 0.9 % 1.13 [ 0.88, 1.47 ]

Subtotal (95% CI) 5445 5444 100.0 % 1.03 [ 1.00, 1.05 ]

Total events: 3827 (Continuous support), 3708 (Usual care)

Heterogeneity: Chi2 = 8.33, df = 8 (P = 0.40); I2 =4%

Test for overall effect: Z = 2.27 (P = 0.023)

2 Other support not permitted

Kashanian 2010 46/50 38/50 5.1 % 1.21 [ 1.02, 1.44 ]

Bruggemann 2007 41/105 38/107 1.3 % 1.10 [ 0.78, 1.56 ]

Madi 1999 48/53 40/56 4.5 % 1.27 [ 1.05, 1.53 ]

Torres 1999 110/217 101/218 4.2 % 1.09 [ 0.90, 1.33 ]

Langer 1998 264/361 254/363 18.5 % 1.05 [ 0.95, 1.15 ]

Breart - Greece 1992 215/295 194/274 14.7 % 1.03 [ 0.93, 1.14 ]

Hofmeyr 1991 74/92 76/97 7.4 % 1.03 [ 0.89, 1.19 ]

Kennell 1991 179/212 137/200 12.9 % 1.23 [ 1.10, 1.38 ]

Klaus 1986 172/186 225/279 31.4 % 1.15 [ 1.07, 1.23 ]

Subtotal (95% CI) 1571 1644 100.0 % 1.12 [ 1.07, 1.16 ]

Total events: 1149 (Continuous support), 1103 (Usual care)

Heterogeneity: Chi2 = 11.93, df = 8 (P = 0.15); I2 =33%

Test for overall effect: Z = 5.43 (P < 0.00001)

Test for subgroup differences: Chi2 = 12.04, df = 1 (P = 0.00), I2 =92%

0.5 0.7 1 1.5 2

Favours usual care Favours support

67Continuous support for women during childbirth (Review)

Analysis 2.4. Comparison 2 Continuous support versus usual care - policy regarding presence of companion,

Outcome 4 Caesarean birth.

Review: Continuous support for women during childbirth

Comparison: 2 Continuous support versus usual care - policy regarding presence of companion

Outcome: 4 Caesarean birth

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Other support permitted

McGrath 2008 30/224 49/196 5.6 % 0.54 [ 0.35, 0.81 ]

Campbell 2006 55/291 53/295 8.3 % 1.05 [ 0.75, 1.48 ]

Hodnett 2002 432/3454 437/3461 62.0 % 0.99 [ 0.87, 1.12 ]

Dickinson 2002 71/499 85/493 11.4 % 0.83 [ 0.62, 1.10 ]

Gagnon 1997 29/209 33/204 4.5 % 0.86 [ 0.54, 1.36 ]

Breart - Belgium 1992 5/133 5/129 0.6 % 0.97 [ 0.29, 3.27 ]

Breart - France 1992 40/654 36/665 5.0 % 1.13 [ 0.73, 1.75 ]

Hemminki 1990b 2/81 3/80 0.3 % 0.66 [ 0.11, 3.84 ]

Hemminki 1990a 0/41 3/38 0.1 % 0.13 [ 0.01, 2.49 ]

Hodnett 1989 12/72 13/73 1.9 % 0.94 [ 0.46, 1.91 ]

Cogan 1988 2/20 1/14 0.2 % 1.40 [ 0.14, 13.98 ]

Subtotal (95% CI) 5678 5648 100.0 % 0.94 [ 0.85, 1.03 ]

Total events: 678 (Continuous support), 718 (Usual care)

Heterogeneity: Chi2 = 11.85, df = 10 (P = 0.29); I2 =16%

Test for overall effect: Z = 1.28 (P = 0.20)

2 Other support not permitted

Kashanian 2010 4/50 12/50 2.0 % 0.33 [ 0.12, 0.96 ]

Morhason-Bello 2009 27/305 68/298 12.7 % 0.39 [ 0.26, 0.59 ]

Bruggemann 2007 11/105 12/107 3.7 % 0.93 [ 0.43, 2.02 ]

Madi 1999 3/53 7/56 1.3 % 0.45 [ 0.12, 1.66 ]

Torres 1999 54/217 46/218 18.5 % 1.18 [ 0.83, 1.67 ]

Langer 1998 85/357 97/356 34.8 % 0.87 [ 0.68, 1.12 ]

Breart - Greece 1992 30/282 34/263 10.4 % 0.82 [ 0.52, 1.31 ]

Hofmeyr 1991 11/92 14/97 4.1 % 0.83 [ 0.40, 1.73 ]

Kennell 1991 17/212 26/200 6.6 % 0.62 [ 0.35, 1.10 ]

0.05 0.2 1 5 20

Favours support Favours usual care

(Continued . . . )

68Continuous support for women during childbirth (Review)

(. . . Continued) Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

Klaus 1986 12/168 46/249 6.0 % 0.39 [ 0.21, 0.71 ]

Subtotal (95% CI) 1841 1894 100.0 % 0.75 [ 0.65, 0.87 ]

Total events: 254 (Continuous support), 362 (Usual care)

Heterogeneity: Chi2 = 26.06, df = 9 (P = 0.002); I2 =65%

Test for overall effect: Z = 3.80 (P = 0.00014)

Test for subgroup differences: Chi2 = 6.10, df = 1 (P = 0.01), I2 =84%

0.05 0.2 1 5 20

Favours support Favours usual care

Analysis 2.5. Comparison 2 Continuous support versus usual care - policy regarding presence of companion,

Outcome 5 Admission to special care nursery.

Review: Continuous support for women during childbirth

Comparison: 2 Continuous support versus usual care - policy regarding presence of companion

Outcome: 5 Admission to special care nursery

Study or subgroup Continuous support Usual care Risk Ratio Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Other support permitted

Hodnett 2002 246/3454 254/3461 0.97 [ 0.82, 1.15 ]

Gagnon 1997 15/209 10/204 1.46 [ 0.67, 3.18 ]

Subtotal (95% CI) 3663 3665 0.99 [ 0.84, 1.17 ]

Total events: 261 (Continuous support), 264 (Usual care)

Heterogeneity: Chi2 = 1.03, df = 1 (P = 0.31); I2 =3%

Test for overall effect: Z = 0.14 (P = 0.89)

2 Other support not permitted

Kashanian 2010 0/50 0/50 0.0 [ 0.0, 0.0 ]

Bruggemann 2007 5/105 6/107 0.85 [ 0.27, 2.70 ]

Torres 1999 12/215 6/213 1.98 [ 0.76, 5.18 ]

Klaus 1986 3/168 17/249 0.26 [ 0.08, 0.88 ]

Kennell 1991 69/212 71/200 0.92 [ 0.70, 1.20 ]

Subtotal (95% CI) 750 819 0.91 [ 0.71, 1.17 ]

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

(Continued . . . )

69Continuous support for women during childbirth (Review)

(. . . Continued) Study or subgroup Continuous support Usual care Risk Ratio Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

Total events: 89 (Continuous support), 100 (Usual care)

Heterogeneity: Chi2 = 6.60, df = 3 (P = 0.09); I2 =55%

Test for overall effect: Z = 0.73 (P = 0.47)

Test for subgroup differences: Chi2 = 0.28, df = 1 (P = 0.60), I2 =0.0%

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

Analysis 2.6. Comparison 2 Continuous support versus usual care - policy regarding presence of companion,

Outcome 6 Postpartum depression.

Review: Continuous support for women during childbirth

Comparison: 2 Continuous support versus usual care - policy regarding presence of companion

Outcome: 6 Postpartum depression

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Other support permitted

Hodnett 2002 245/2816 277/2751 100.0 % 0.86 [ 0.73, 1.02 ]

Subtotal (95% CI) 2816 2751 100.0 % 0.86 [ 0.73, 1.02 ]

Total events: 245 (Continuous support), 277 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 1.75 (P = 0.080)

2 Other support not permitted

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]

Total events: 0 (Continuous support), 0 (Usual care)

Heterogeneity: not applicable

Test for overall effect: not applicable

0.5 0.7 1 1.5 2

Favours support Favours usual care

70Continuous support for women during childbirth (Review)

Analysis 2.7. Comparison 2 Continuous support versus usual care - policy regarding presence of companion,

Outcome 7 Negative rating of/negative feelings about birth experience.

Review: Continuous support for women during childbirth

Comparison: 2 Continuous support versus usual care - policy regarding presence of companion

Outcome: 7 Negative rating of/negative feelings about birth experience

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Other support permitted

Campbell 2006 95/229 197/265 50.3 % 0.56 [ 0.47, 0.66 ]

Hodnett 2002 96/2818 117/2751 20.6 % 0.80 [ 0.61, 1.04 ]

Dickinson 2002 75/499 74/493 16.5 % 1.00 [ 0.74, 1.35 ]

Breart - Belgium 1992 24/133 30/131 6.3 % 0.79 [ 0.49, 1.27 ]

Breart - France 1992 30/656 35/664 6.4 % 0.87 [ 0.54, 1.40 ]

Subtotal (95% CI) 4335 4304 100.0 % 0.70 [ 0.62, 0.78 ]

Total events: 320 (Continuous support), 453 (Usual care)

Heterogeneity: Chi2 = 14.50, df = 4 (P = 0.01); I2 =72%

Test for overall effect: Z = 5.92 (P < 0.00001)

2 Other support not permitted

Morhason-Bello 2009 108/293 196/292 39.7 % 0.55 [ 0.46, 0.65 ]

Bruggemann 2007 7/105 17/107 1.6 % 0.42 [ 0.18, 0.97 ]

Torres 1999 35/206 43/211 7.1 % 0.83 [ 0.56, 1.25 ]

Langer 1998 98/361 129/363 24.0 % 0.76 [ 0.61, 0.95 ]

Hofmeyr 1991 38/92 73/97 15.9 % 0.55 [ 0.42, 0.72 ]

Kennell 1991 47/212 71/200 11.7 % 0.62 [ 0.46, 0.85 ]

Subtotal (95% CI) 1269 1270 100.0 % 0.62 [ 0.56, 0.69 ]

Total events: 333 (Continuous support), 529 (Usual care)

Heterogeneity: Chi2 = 9.16, df = 5 (P = 0.10); I2 =45%

Test for overall effect: Z = 8.78 (P < 0.00001)

Test for subgroup differences: Chi2 = 2.03, df = 1 (P = 0.15), I2 =51%

0.5 0.7 1 1.5 2

Favours support Favours usual care

71Continuous support for women during childbirth (Review)

Analysis 2.8. Comparison 2 Continuous support versus usual care - policy regarding presence of companion,

Outcome 8 Breastfeeding at 1-2 months postpartum.

Review: Continuous support for women during childbirth

Comparison: 2 Continuous support versus usual care - policy regarding presence of companion

Outcome: 8 Breastfeeding at 1-2 months postpartum

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Other support permitted

Hodnett 2002 1312/2339 1283/2220 100.0 % 0.97 [ 0.92, 1.02 ]

Subtotal (95% CI) 2339 2220 100.0 % 0.97 [ 0.92, 1.02 ]

Total events: 1312 (Continuous support), 1283 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 1.16 (P = 0.25)

2 Other support not permitted

Hofmeyr 1991 58/74 51/75 14.5 % 1.15 [ 0.95, 1.40 ]

Langer 1998 266/334 247/321 85.5 % 1.04 [ 0.95, 1.12 ]

Subtotal (95% CI) 408 396 100.0 % 1.05 [ 0.98, 1.13 ]

Total events: 324 (Continuous support), 298 (Usual care)

Heterogeneity: Chi2 = 0.99, df = 1 (P = 0.32); I2 =0.0%

Test for overall effect: Z = 1.31 (P = 0.19)

Test for subgroup differences: Chi2 = 3.02, df = 1 (P = 0.08), I2 =67%

0.5 0.7 1 1.5 2

Favours support Favours usual care

72Continuous support for women during childbirth (Review)

Analysis 3.1. Comparison 3 Continuous support versus usual care - availability of epidural analgesia,

Outcome 1 Any analgesia/anaesthesia.

Review: Continuous support for women during childbirth

Comparison: 3 Continuous support versus usual care - availability of epidural analgesia

Outcome: 1 Any analgesia/anaesthesia

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Epidural analgesia routinely available

Hemminki 1990a 25/41 23/38 0.2 % 1.01 [ 0.71, 1.44 ]

Kennell 1991 93/212 150/200 0.7 % 0.58 [ 0.49, 0.69 ]

Hemminki 1990b 45/81 52/80 0.3 % 0.85 [ 0.66, 1.10 ]

Gagnon 1997 141/209 142/204 1.2 % 0.97 [ 0.85, 1.10 ]

Langer 1998 295/361 302/363 4.6 % 0.98 [ 0.92, 1.05 ]

Breart - France 1992 281/656 319/664 1.5 % 0.89 [ 0.79, 1.00 ]

Breart - Belgium 1992 55/133 62/131 0.3 % 0.87 [ 0.67, 1.15 ]

Hodnett 2002 3077/3454 3159/3461 86.7 % 0.98 [ 0.96, 0.99 ]

Campbell 2006 247/300 260/300 4.5 % 0.95 [ 0.89, 1.02 ]

Subtotal (95% CI) 5447 5441 100.0 % 0.97 [ 0.96, 0.98 ]

Total events: 4259 (Continuous support), 4469 (Usual care)

Heterogeneity: Chi2 = 37.83, df = 8 (P<0.00001); I2 =79%

Test for overall effect: Z = 4.19 (P = 0.000028)

2 Epidural analgesia not routinely available

Madi 1999 28/53 41/56 37.8 % 0.72 [ 0.53, 0.97 ]

Morhason-Bello 2009 84/293 89/292 54.2 % 0.94 [ 0.73, 1.21 ]

Klaus 1986 2/186 10/279 1.5 % 0.30 [ 0.07, 1.35 ]

Hofmeyr 1991 11/92 15/97 6.5 % 0.77 [ 0.37, 1.59 ]

Subtotal (95% CI) 624 724 100.0 % 0.83 [ 0.69, 0.99 ]

Total events: 125 (Continuous support), 155 (Usual care)

Heterogeneity: Chi2 = 3.58, df = 3 (P = 0.31); I2 =16%

Test for overall effect: Z = 2.03 (P = 0.042)

Test for subgroup differences: Chi2 = 2.89, df = 1 (P = 0.09), I2 =65%

0.5 0.7 1 1.5 2

Favours support Favours usual care

73Continuous support for women during childbirth (Review)

Analysis 3.2. Comparison 3 Continuous support versus usual care - availability of epidural analgesia,

Outcome 2 Synthetic oxytocin during labour.

Review: Continuous support for women during childbirth

Comparison: 3 Continuous support versus usual care - availability of epidural analgesia

Outcome: 2 Synthetic oxytocin during labour

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Epidural analgesia routinely available

Bruggemann 2007 104/105 107/107 75.7 % 0.99 [ 0.96, 1.02 ]

Kennell 1991 36/212 46/200 0.3 % 0.74 [ 0.50, 1.09 ]

Breart - Belgium 1992 55/132 64/129 0.7 % 0.84 [ 0.64, 1.10 ]

Breart - France 1992 383/654 371/666 5.9 % 1.05 [ 0.96, 1.15 ]

Torres 1999 167/217 172/218 5.2 % 0.98 [ 0.88, 1.08 ]

Gagnon 1997 82/209 96/204 1.0 % 0.83 [ 0.67, 1.04 ]

Campbell 2006 134/300 145/300 1.8 % 0.92 [ 0.78, 1.10 ]

Hodnett 2002 1040/3454 942/3461 9.3 % 1.11 [ 1.03, 1.19 ]

Subtotal (95% CI) 5283 5285 100.0 % 1.00 [ 0.98, 1.02 ]

Total events: 2001 (Continuous support), 1943 (Usual care)

Heterogeneity: Chi2 = 16.22, df = 7 (P = 0.02); I2 =57%

Test for overall effect: Z = 0.15 (P = 0.88)

2 Epidural analgesia not routinely available

Hofmeyr 1991 16/92 17/97 2.1 % 0.99 [ 0.53, 1.85 ]

Klaus 1986 4/168 37/249 0.8 % 0.16 [ 0.06, 0.44 ]

Madi 1999 7/53 17/56 1.3 % 0.44 [ 0.20, 0.96 ]

Breart - Greece 1992 224/287 193/265 87.1 % 1.07 [ 0.97, 1.18 ]

Kashanian 2010 11/50 19/50 2.0 % 0.58 [ 0.31, 1.09 ]

Morhason-Bello 2009 51/293 56/292 6.8 % 0.91 [ 0.64, 1.28 ]

Subtotal (95% CI) 943 1009 100.0 % 1.02 [ 0.93, 1.11 ]

Total events: 313 (Continuous support), 339 (Usual care)

Heterogeneity: Chi2 = 21.80, df = 5 (P = 0.00057); I2 =77%

Test for overall effect: Z = 0.39 (P = 0.70)

Test for subgroup differences: Chi2 = 0.17, df = 1 (P = 0.68), I2 =0.0%

0.2 0.5 1 2 5

Favours support Favours usual care

74Continuous support for women during childbirth (Review)

Analysis 3.3. Comparison 3 Continuous support versus usual care - availability of epidural analgesia,

Outcome 3 Spontaneous vaginal birth.

Review: Continuous support for women during childbirth

Comparison: 3 Continuous support versus usual care - availability of epidural analgesia

Outcome: 3 Spontaneous vaginal birth

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Epidural analgesia routinely available

Hemminki 1990b 76/81 72/80 6.0 % 1.04 [ 0.95, 1.14 ]

Hemminki 1990a 38/41 34/38 2.6 % 1.04 [ 0.90, 1.19 ]

Kennell 1991 179/212 137/200 4.1 % 1.23 [ 1.10, 1.38 ]

Breart - France 1992 453/656 424/664 8.5 % 1.08 [ 1.00, 1.17 ]

Hodnett 1989 47/72 42/73 0.8 % 1.13 [ 0.88, 1.47 ]

Dickinson 2002 280/499 239/493 3.5 % 1.16 [ 1.03, 1.30 ]

Hodnett 2002 2481/3454 2463/3461 56.9 % 1.01 [ 0.98, 1.04 ]

Campbell 2006 223/300 220/300 5.6 % 1.01 [ 0.92, 1.11 ]

Bruggemann 2007 41/105 38/107 0.4 % 1.10 [ 0.78, 1.56 ]

Breart - Belgium 1992 97/133 87/131 2.0 % 1.10 [ 0.94, 1.29 ]

Gagnon 1997 132/209 127/204 2.3 % 1.01 [ 0.87, 1.18 ]

Langer 1998 264/361 254/363 6.0 % 1.05 [ 0.95, 1.15 ]

Torres 1999 110/217 101/218 1.3 % 1.09 [ 0.90, 1.33 ]

Subtotal (95% CI) 6340 6332 100.0 % 1.04 [ 1.01, 1.06 ]

Total events: 4421 (Continuous support), 4238 (Usual care)

Heterogeneity: Chi2 = 18.67, df = 12 (P = 0.10); I2 =36%

Test for overall effect: Z = 3.26 (P = 0.0011)

2 Epidural analgesia not routinely available

Madi 1999 48/53 40/56 7.1 % 1.27 [ 1.05, 1.53 ]

Kashanian 2010 46/50 38/50 8.0 % 1.21 [ 1.02, 1.44 ]

Klaus 1986 172/186 225/279 49.8 % 1.15 [ 1.07, 1.23 ]

Breart - Greece 1992 215/295 194/274 23.4 % 1.03 [ 0.93, 1.14 ]

Hofmeyr 1991 74/92 76/97 11.8 % 1.03 [ 0.89, 1.19 ]

Subtotal (95% CI) 676 756 100.0 % 1.12 [ 1.06, 1.17 ]

Total events: 555 (Continuous support), 573 (Usual care)

Heterogeneity: Chi2 = 6.81, df = 4 (P = 0.15); I2 =41%

Test for overall effect: Z = 4.33 (P = 0.000015)

Test for subgroup differences: Chi2 = 6.82, df = 1 (P = 0.01), I2 =85%

0.5 0.7 1 1.5 2

Favours usual care Favours support

75Continuous support for women during childbirth (Review)

Analysis 3.4. Comparison 3 Continuous support versus usual care - availability of epidural analgesia,

Outcome 4 Caesarean birth.

Review: Continuous support for women during childbirth

Comparison: 3 Continuous support versus usual care - availability of epidural analgesia

Outcome: 4 Caesarean birth

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Epidural analgesia routinely available

Hodnett 2002 432/3454 437/3461 48.6 % 0.99 [ 0.87, 1.12 ]

Campbell 2006 55/291 53/295 6.5 % 1.05 [ 0.75, 1.48 ]

Bruggemann 2007 11/105 12/107 1.3 % 0.93 [ 0.43, 2.02 ]

McGrath 2008 30/224 49/196 4.4 % 0.54 [ 0.35, 0.81 ]

Breart - Belgium 1992 5/133 5/129 0.5 % 0.97 [ 0.29, 3.27 ]

Breart - France 1992 40/654 36/665 3.9 % 1.13 [ 0.73, 1.75 ]

Kennell 1991 17/212 26/200 2.2 % 0.62 [ 0.35, 1.10 ]

Hemminki 1990b 2/81 3/80 0.2 % 0.66 [ 0.11, 3.84 ]

Dickinson 2002 71/499 85/493 9.0 % 0.83 [ 0.62, 1.10 ]

Torres 1999 54/217 46/218 6.3 % 1.18 [ 0.83, 1.67 ]

Langer 1998 85/357 97/356 11.9 % 0.87 [ 0.68, 1.12 ]

Gagnon 1997 29/209 33/204 3.6 % 0.86 [ 0.54, 1.36 ]

Hemminki 1990a 0/41 3/38 0.1 % 0.13 [ 0.01, 2.49 ]

Hodnett 1989 12/72 13/73 1.5 % 0.94 [ 0.46, 1.91 ]

Subtotal (95% CI) 6549 6515 100.0 % 0.93 [ 0.86, 1.02 ]

Total events: 843 (Continuous support), 898 (Usual care)

Heterogeneity: Chi2 = 15.73, df = 13 (P = 0.26); I2 =17%

Test for overall effect: Z = 1.54 (P = 0.12)

2 Epidural analgesia not routinely available

Klaus 1986 12/168 46/249 16.6 % 0.39 [ 0.21, 0.71 ]

Morhason-Bello 2009 27/305 68/298 34.9 % 0.39 [ 0.26, 0.59 ]

Madi 1999 3/53 7/56 3.6 % 0.45 [ 0.12, 1.66 ]

Breart - Greece 1992 30/282 34/263 28.4 % 0.82 [ 0.52, 1.31 ]

Hofmeyr 1991 11/92 14/97 11.2 % 0.83 [ 0.40, 1.73 ]

Kashanian 2010 4/50 12/50 5.4 % 0.33 [ 0.12, 0.96 ]

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

(Continued . . . )

76Continuous support for women during childbirth (Review)

(. . . Continued) Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

Subtotal (95% CI) 950 1013 100.0 % 0.52 [ 0.41, 0.67 ]

Total events: 87 (Continuous support), 181 (Usual care)

Heterogeneity: Chi2 = 8.88, df = 5 (P = 0.11); I2 =44%

Test for overall effect: Z = 5.19 (P < 0.00001)

3 Unknown availability of epidural analgesia

Cogan 1988 2/20 1/14 100.0 % 1.40 [ 0.14, 13.98 ]

Subtotal (95% CI) 20 14 100.0 % 1.40 [ 0.14, 13.98 ]

Total events: 2 (Continuous support), 1 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 0.29 (P = 0.77)

Test for subgroup differences: Chi2 = 19.40, df = 2 (P = 0.00), I2 =90%

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

Analysis 3.5. Comparison 3 Continuous support versus usual care - availability of epidural analgesia,

Outcome 5 Admission to special care nursery.

Review: Continuous support for women during childbirth

Comparison: 3 Continuous support versus usual care - availability of epidural analgesia

Outcome: 5 Admission to special care nursery

Study or subgroup Continuous support Usual care Risk Ratio Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Epidural analgesia routinely available

Kennell 1991 69/212 71/200 0.92 [ 0.70, 1.20 ]

Torres 1999 12/215 6/213 1.98 [ 0.76, 5.18 ]

Gagnon 1997 15/209 10/204 1.46 [ 0.67, 3.18 ]

Bruggemann 2007 5/105 6/107 0.85 [ 0.27, 2.70 ]

Hodnett 2002 246/3454 254/3461 0.97 [ 0.82, 1.15 ]

Subtotal (95% CI) 4195 4185 0.98 [ 0.85, 1.13 ]

Total events: 347 (Continuous support), 347 (Usual care)

Heterogeneity: Chi2 = 3.39, df = 4 (P = 0.49); I2 =0.0%

Test for overall effect: Z = 0.27 (P = 0.79)

0.02 0.1 1 10 50

Favours support Favours usual care

(Continued . . . )

77Continuous support for women during childbirth (Review)

(. . . Continued) Study or subgroup Continuous support Usual care Risk Ratio Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

2 Epidural analgesia not routinely available

Klaus 1986 3/168 17/249 0.26 [ 0.08, 0.88 ]

Kashanian 2010 0/50 0/50 0.0 [ 0.0, 0.0 ]

Subtotal (95% CI) 218 299 0.26 [ 0.08, 0.88 ]

Total events: 3 (Continuous support), 17 (Usual care)

Heterogeneity: Chi2 = 0.0, df = 0 (P = 1.00); I2 =0.0%

Test for overall effect: Z = 2.17 (P = 0.030)

Test for subgroup differences: Chi2 = 4.51, df = 1 (P = 0.03), I2 =78%

0.02 0.1 1 10 50

Favours support Favours usual care

Analysis 3.6. Comparison 3 Continuous support versus usual care - availability of epidural analgesia,

Outcome 6 Postpartum depression.

Review: Continuous support for women during childbirth

Comparison: 3 Continuous support versus usual care - availability of epidural analgesia

Outcome: 6 Postpartum depression

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Epidural analgesia routinely available

Hodnett 2002 245/3454 277/3461 100.0 % 0.89 [ 0.75, 1.05 ]

Subtotal (95% CI) 3454 3461 100.0 % 0.89 [ 0.75, 1.05 ]

Total events: 245 (Continuous support), 277 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 1.43 (P = 0.15)

2 Epidural analgesia not routinely available

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]

Total events: 0 (Continuous support), 0 (Usual care)

Heterogeneity: not applicable

Test for overall effect: not applicable

0.05 0.2 1 5 20

Favours support Favours usual care

78Continuous support for women during childbirth (Review)

Analysis 3.7. Comparison 3 Continuous support versus usual care - availability of epidural analgesia,

Outcome 7 Negative rating of/negative feelings about birth experience.

Review: Continuous support for women during childbirth

Comparison: 3 Continuous support versus usual care - availability of epidural analgesia

Outcome: 7 Negative rating of/negative feelings about birth experience

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Epidural analgesia routinely available

Bruggemann 2007 7/105 17/107 1.3 % 0.42 [ 0.18, 0.97 ]

Hodnett 2002 96/2818 117/2751 13.2 % 0.80 [ 0.61, 1.04 ]

Campbell 2006 95/229 197/265 32.3 % 0.56 [ 0.47, 0.66 ]

Torres 1999 35/206 43/211 5.7 % 0.83 [ 0.56, 1.25 ]

Dickinson 2002 75/499 74/493 10.6 % 1.00 [ 0.74, 1.35 ]

Breart - Belgium 1992 24/133 30/131 4.0 % 0.79 [ 0.49, 1.27 ]

Langer 1998 98/361 129/363 19.4 % 0.76 [ 0.61, 0.95 ]

Kennell 1991 47/212 71/200 9.4 % 0.62 [ 0.46, 0.85 ]

Breart - France 1992 30/656 35/664 4.1 % 0.87 [ 0.54, 1.40 ]

Subtotal (95% CI) 5219 5185 100.0 % 0.70 [ 0.64, 0.77 ]

Total events: 507 (Continuous support), 713 (Usual care)

Heterogeneity: Chi2 = 17.78, df = 8 (P = 0.02); I2 =55%

Test for overall effect: Z = 7.16 (P < 0.00001)

2 Epidural analgesia not routinely available

Hofmeyr 1991 38/92 73/97 28.5 % 0.55 [ 0.42, 0.72 ]

Morhason-Bello 2009 108/293 196/292 71.5 % 0.55 [ 0.46, 0.65 ]

Subtotal (95% CI) 385 389 100.0 % 0.55 [ 0.48, 0.63 ]

Total events: 146 (Continuous support), 269 (Usual care)

Heterogeneity: Chi2 = 0.00, df = 1 (P = 1.00); I2 =0.0%

Test for overall effect: Z = 8.18 (P < 0.00001)

Test for subgroup differences: Chi2 = 7.92, df = 1 (P = 0.00), I2 =87%

0.5 0.7 1 1.5 2

Favours support Favours usual care

79Continuous support for women during childbirth (Review)

Analysis 3.8. Comparison 3 Continuous support versus usual care - availability of epidural analgesia,

Outcome 8 Breastfeeding at 1-2 months postpartum.

Review: Continuous support for women during childbirth

Comparison: 3 Continuous support versus usual care - availability of epidural analgesia

Outcome: 8 Breastfeeding at 1-2 months postpartum

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Epidural analgesia routinely available

Langer 1998 266/334 247/321 28.1 % 1.04 [ 0.95, 1.12 ]

Hodnett 2002 1312/2339 1283/2220 71.9 % 0.97 [ 0.92, 1.02 ]

Subtotal (95% CI) 2673 2541 100.0 % 0.99 [ 0.95, 1.03 ]

Total events: 1578 (Continuous support), 1530 (Usual care)

Heterogeneity: Chi2 = 1.75, df = 1 (P = 0.19); I2 =43%

Test for overall effect: Z = 0.54 (P = 0.59)

2 Epidural analgesia not routinely available

Hofmeyr 1991 58/74 51/75 100.0 % 1.15 [ 0.95, 1.40 ]

Subtotal (95% CI) 74 75 100.0 % 1.15 [ 0.95, 1.40 ]

Total events: 58 (Continuous support), 51 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 1.42 (P = 0.16)

Test for subgroup differences: Chi2 = 2.26, df = 1 (P = 0.13), I2 =56%

0.5 0.7 1 1.5 2

Favours support Favours usual care

80Continuous support for women during childbirth (Review)

Analysis 4.1. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 1

Any analgesia/anaesthesia.

Review: Continuous support for women during childbirth

Comparison: 4 Continuous support versus usual care - policy about routine EFM

Outcome: 1 Any analgesia/anaesthesia

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Setting had routine EFM

Kennell 1991 93/212 150/200 0.8 % 0.58 [ 0.49, 0.69 ]

Hemminki 1990a 25/41 23/38 0.2 % 1.01 [ 0.71, 1.44 ]

Hemminki 1990b 45/81 52/80 0.4 % 0.85 [ 0.66, 1.10 ]

Campbell 2006 247/300 260/300 4.8 % 0.95 [ 0.89, 1.02 ]

Hodnett 2002 3077/3454 3159/3461 92.6 % 0.98 [ 0.96, 0.99 ]

Gagnon 1997 141/209 142/204 1.3 % 0.97 [ 0.85, 1.10 ]

Subtotal (95% CI) 4297 4283 100.0 % 0.97 [ 0.96, 0.99 ]

Total events: 3628 (Continuous support), 3786 (Usual care)

Heterogeneity: Chi2 = 35.18, df = 5 (P<0.00001); I2 =86%

Test for overall effect: Z = 3.92 (P = 0.000089)

2 Setting did not have routine EFM

Klaus 1986 2/186 10/279 0.2 % 0.30 [ 0.07, 1.35 ]

Morhason-Bello 2009 84/293 89/292 6.4 % 0.94 [ 0.73, 1.21 ]

Madi 1999 28/53 41/56 4.4 % 0.72 [ 0.53, 0.97 ]

Langer 1998 295/361 302/363 88.3 % 0.98 [ 0.92, 1.05 ]

Hofmeyr 1991 11/92 15/97 0.8 % 0.77 [ 0.37, 1.59 ]

Subtotal (95% CI) 985 1087 100.0 % 0.96 [ 0.90, 1.03 ]

Total events: 420 (Continuous support), 457 (Usual care)

Heterogeneity: Chi2 = 6.58, df = 4 (P = 0.16); I2 =39%

Test for overall effect: Z = 1.19 (P = 0.23)

3 Policy about routine EFM not known

Breart - Belgium 1992 55/133 62/128 16.2 % 0.85 [ 0.65, 1.12 ]

Breart - France 1992 281/652 319/666 83.8 % 0.90 [ 0.80, 1.01 ]

Subtotal (95% CI) 785 794 100.0 % 0.89 [ 0.80, 0.99 ]

Total events: 336 (Continuous support), 381 (Usual care)

Heterogeneity: Chi2 = 0.12, df = 1 (P = 0.73); I2 =0.0%

Test for overall effect: Z = 2.06 (P = 0.039)

Test for subgroup differences: Chi2 = 2.31, df = 2 (P = 0.32), I2 =13%

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

81Continuous support for women during childbirth (Review)

Analysis 4.2. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 2

Synthetic oxytocin during labour.

Review: Continuous support for women during childbirth

Comparison: 4 Continuous support versus usual care - policy about routine EFM

Outcome: 2 Synthetic oxytocin during labour

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Setting had routine EFM

Campbell 2006 134/300 145/300 14.1 % 0.92 [ 0.78, 1.10 ]

Gagnon 1997 82/209 96/204 8.4 % 0.83 [ 0.67, 1.04 ]

Hodnett 2002 1040/3454 942/3461 74.9 % 1.11 [ 1.03, 1.19 ]

Kennell 1991 36/212 46/200 2.7 % 0.74 [ 0.50, 1.09 ]

Subtotal (95% CI) 4175 4165 100.0 % 1.04 [ 0.98, 1.11 ]

Total events: 1292 (Continuous support), 1229 (Usual care)

Heterogeneity: Chi2 = 11.18, df = 3 (P = 0.01); I2 =73%

Test for overall effect: Z = 1.25 (P = 0.21)

2 Setting did not have routine EFM

Klaus 1986 4/168 37/249 0.1 % 0.16 [ 0.06, 0.44 ]

Hofmeyr 1991 16/92 17/97 0.2 % 0.99 [ 0.53, 1.85 ]

Morhason-Bello 2009 51/293 56/292 0.6 % 0.91 [ 0.64, 1.28 ]

Kashanian 2010 11/50 19/50 0.2 % 0.58 [ 0.31, 1.09 ]

Madi 1999 7/53 17/56 0.1 % 0.44 [ 0.20, 0.96 ]

Bruggemann 2007 104/105 107/107 98.9 % 0.99 [ 0.96, 1.02 ]

Subtotal (95% CI) 761 851 100.0 % 0.99 [ 0.96, 1.01 ]

Total events: 193 (Continuous support), 253 (Usual care)

Heterogeneity: Chi2 = 19.49, df = 5 (P = 0.002); I2 =74%

Test for overall effect: Z = 0.99 (P = 0.32)

3 Policy about routine EFM not known

Torres 1999 167/217 172/218 29.6 % 0.98 [ 0.88, 1.08 ]

Breart - Greece 1992 224/287 193/265 32.3 % 1.07 [ 0.97, 1.18 ]

Breart - Belgium 1992 55/132 64/129 4.2 % 0.84 [ 0.64, 1.10 ]

Breart - France 1992 383/654 371/666 33.9 % 1.05 [ 0.96, 1.15 ]

Subtotal (95% CI) 1290 1278 100.0 % 1.02 [ 0.97, 1.08 ]

Total events: 829 (Continuous support), 800 (Usual care)

Heterogeneity: Chi2 = 4.20, df = 3 (P = 0.24); I2 =29%

Test for overall effect: Z = 0.89 (P = 0.37)

Test for subgroup differences: Chi2 = 3.32, df = 2 (P = 0.19), I2 =40%

0.05 0.2 1 5 20

Favours support Favours usual care

82Continuous support for women during childbirth (Review)

Analysis 4.3. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 3

Spontaneous vaginal birth.

Review: Continuous support for women during childbirth

Comparison: 4 Continuous support versus usual care - policy about routine EFM

Outcome: 3 Spontaneous vaginal birth

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Setting had routine EFM

Hemminki 1990b 76/81 72/80 7.3 % 1.04 [ 0.95, 1.14 ]

Hodnett 1989 47/72 42/73 0.9 % 1.13 [ 0.88, 1.47 ]

Kennell 1991 179/212 137/200 5.1 % 1.23 [ 1.10, 1.38 ]

Hemminki 1990a 38/41 34/38 3.2 % 1.04 [ 0.90, 1.19 ]

Dickinson 2002 280/499 239/493 4.3 % 1.16 [ 1.03, 1.30 ]

Gagnon 1997 132/209 127/204 2.8 % 1.01 [ 0.87, 1.18 ]

Campbell 2006 223/300 220/300 6.8 % 1.01 [ 0.92, 1.11 ]

Hodnett 2002 2481/3454 2463/3461 69.6 % 1.01 [ 0.98, 1.04 ]

Subtotal (95% CI) 4868 4849 100.0 % 1.03 [ 1.01, 1.06 ]

Total events: 3456 (Continuous support), 3334 (Usual care)

Heterogeneity: Chi2 = 16.37, df = 7 (P = 0.02); I2 =57%

Test for overall effect: Z = 2.37 (P = 0.018)

2 Setting did not have routine EFM

Klaus 1986 172/186 225/279 46.1 % 1.15 [ 1.07, 1.23 ]

Bruggemann 2007 41/105 38/107 1.9 % 1.10 [ 0.78, 1.56 ]

Madi 1999 48/53 40/56 6.6 % 1.27 [ 1.05, 1.53 ]

Langer 1998 264/361 254/363 27.2 % 1.05 [ 0.95, 1.15 ]

Hofmeyr 1991 74/92 76/97 10.9 % 1.03 [ 0.89, 1.19 ]

Kashanian 2010 46/50 38/50 7.4 % 1.21 [ 1.02, 1.44 ]

Subtotal (95% CI) 847 952 100.0 % 1.12 [ 1.06, 1.17 ]

Total events: 645 (Continuous support), 671 (Usual care)

Heterogeneity: Chi2 = 6.41, df = 5 (P = 0.27); I2 =22%

Test for overall effect: Z = 4.48 (P < 0.00001)

3 Policy about routine EFM not known

Breart - Greece 1992 202/282 183/263 26.6 % 1.03 [ 0.92, 1.15 ]

Torres 1999 110/217 101/218 8.3 % 1.09 [ 0.90, 1.33 ]

Breart - Belgium 1992 97/133 85/129 12.0 % 1.11 [ 0.94, 1.30 ]

0.5 0.7 1 1.5 2

Favours usual care Favours support

(Continued . . . )

83Continuous support for women during childbirth (Review)

(. . . Continued) Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

Breart - France 1992 451/654 425/665 53.1 % 1.08 [ 1.00, 1.17 ]

Subtotal (95% CI) 1286 1275 100.0 % 1.07 [ 1.01, 1.13 ]

Total events: 860 (Continuous support), 794 (Usual care)

Heterogeneity: Chi2 = 0.75, df = 3 (P = 0.86); I2 =0.0%

Test for overall effect: Z = 2.37 (P = 0.018)

Test for subgroup differences: Chi2 = 8.78, df = 2 (P = 0.01), I2 =77%

0.5 0.7 1 1.5 2

Favours usual care Favours support

Analysis 4.4. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 4

Caesarean birth.

Review: Continuous support for women during childbirth

Comparison: 4 Continuous support versus usual care - policy about routine EFM

Outcome: 4 Caesarean birth

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Setting had routine EFM

Dickinson 2002 71/499 85/493 11.8 % 0.83 [ 0.62, 1.10 ]

Hodnett 2002 432/3454 437/3461 63.9 % 0.99 [ 0.87, 1.12 ]

Kennell 1991 17/212 26/200 2.9 % 0.62 [ 0.35, 1.10 ]

Gagnon 1997 29/209 33/204 4.7 % 0.86 [ 0.54, 1.36 ]

Campbell 2006 55/291 53/295 8.5 % 1.05 [ 0.75, 1.48 ]

Hemminki 1990a 0/41 3/38 0.1 % 0.13 [ 0.01, 2.49 ]

Hemminki 1990b 2/81 3/80 0.3 % 0.66 [ 0.11, 3.84 ]

Hodnett 1989 12/72 13/73 1.9 % 0.94 [ 0.46, 1.91 ]

McGrath 2008 30/224 49/196 5.8 % 0.54 [ 0.35, 0.81 ]

Subtotal (95% CI) 5083 5040 100.0 % 0.92 [ 0.83, 1.01 ]

Total events: 648 (Continuous support), 702 (Usual care)

Heterogeneity: Chi2 = 12.84, df = 8 (P = 0.12); I2 =38%

Test for overall effect: Z = 1.72 (P = 0.086)

0.05 0.2 1 5 20

Favours support Favours usual care

(Continued . . . )

84Continuous support for women during childbirth (Review)

(. . . Continued) Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

2 Setting did not have routine EFM

Klaus 1986 12/168 46/249 9.3 % 0.39 [ 0.21, 0.71 ]

Langer 1998 85/357 97/356 53.9 % 0.87 [ 0.68, 1.12 ]

Hofmeyr 1991 11/92 14/97 6.3 % 0.83 [ 0.40, 1.73 ]

Morhason-Bello 2009 27/305 68/298 19.7 % 0.39 [ 0.26, 0.59 ]

Kashanian 2010 4/50 12/50 3.0 % 0.33 [ 0.12, 0.96 ]

Madi 1999 3/53 7/56 2.0 % 0.45 [ 0.12, 1.66 ]

Bruggemann 2007 11/105 12/107 5.7 % 0.93 [ 0.43, 2.02 ]

Subtotal (95% CI) 1130 1213 100.0 % 0.66 [ 0.55, 0.80 ]

Total events: 153 (Continuous support), 256 (Usual care)

Heterogeneity: Chi2 = 17.11, df = 6 (P = 0.01); I2 =65%

Test for overall effect: Z = 4.38 (P = 0.000012)

3 Policy about routine EFM not known

Cogan 1988 2/20 1/14 1.0 % 1.40 [ 0.14, 13.98 ]

Breart - Greece 1992 30/282 34/263 24.5 % 0.82 [ 0.52, 1.31 ]

Torres 1999 54/217 46/218 43.7 % 1.18 [ 0.83, 1.67 ]

Breart - France 1992 40/654 36/665 27.3 % 1.13 [ 0.73, 1.75 ]

Breart - Belgium 1992 5/133 5/129 3.5 % 0.97 [ 0.29, 3.27 ]

Subtotal (95% CI) 1306 1289 100.0 % 1.06 [ 0.84, 1.33 ]

Total events: 131 (Continuous support), 122 (Usual care)

Heterogeneity: Chi2 = 1.68, df = 4 (P = 0.79); I2 =0.0%

Test for overall effect: Z = 0.51 (P = 0.61)

Test for subgroup differences: Chi2 = 12.38, df = 2 (P = 0.00), I2 =84%

0.05 0.2 1 5 20

Favours support Favours usual care

85Continuous support for women during childbirth (Review)

Analysis 4.5. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 5

Admission to special care nursery.

Review: Continuous support for women during childbirth

Comparison: 4 Continuous support versus usual care - policy about routine EFM

Outcome: 5 Admission to special care nursery

Study or subgroup Continuous support Usual care Risk Ratio Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Setting had routine EFM

Hodnett 2002 246/3454 254/3461 0.97 [ 0.82, 1.15 ]

Kennell 1991 69/212 71/200 0.92 [ 0.70, 1.20 ]

Gagnon 1997 15/209 10/204 1.46 [ 0.67, 3.18 ]

Subtotal (95% CI) 3875 3865 0.97 [ 0.84, 1.11 ]

Total events: 330 (Continuous support), 335 (Usual care)

Heterogeneity: Chi2 = 1.25, df = 2 (P = 0.54); I2 =0.0%

Test for overall effect: Z = 0.45 (P = 0.66)

2 Setting did not have routine EFM

Kashanian 2010 0/50 0/50 0.0 [ 0.0, 0.0 ]

Klaus 1986 3/168 17/249 0.26 [ 0.08, 0.88 ]

Bruggemann 2007 5/105 6/107 0.85 [ 0.27, 2.70 ]

Subtotal (95% CI) 323 406 0.48 [ 0.21, 1.12 ]

Total events: 8 (Continuous support), 23 (Usual care)

Heterogeneity: Chi2 = 1.90, df = 1 (P = 0.17); I2 =47%

Test for overall effect: Z = 1.70 (P = 0.090)

3 Policy about routine EFM not known

Torres 1999 12/215 6/213 1.98 [ 0.76, 5.18 ]

Subtotal (95% CI) 215 213 1.98 [ 0.76, 5.18 ]

Total events: 12 (Continuous support), 6 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 1.39 (P = 0.16)

Test for subgroup differences: Chi2 = 4.76, df = 2 (P = 0.09), I2 =58%

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

86Continuous support for women during childbirth (Review)

Analysis 4.6. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 6

Postpartum depression.

Review: Continuous support for women during childbirth

Comparison: 4 Continuous support versus usual care - policy about routine EFM

Outcome: 6 Postpartum depression

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Setting had routine EFM

Hodnett 2002 245/3454 277/3461 100.0 % 0.89 [ 0.75, 1.05 ]

Subtotal (95% CI) 3454 3461 100.0 % 0.89 [ 0.75, 1.05 ]

Total events: 245 (Continuous support), 277 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 1.43 (P = 0.15)

2 Setting did not have routine EFM

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]

Total events: 0 (Continuous support), 0 (Usual care)

Heterogeneity: not applicable

Test for overall effect: not applicable

0.05 0.2 1 5 20

Favours support Favours usual care

87Continuous support for women during childbirth (Review)

Analysis 4.7. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 7

Negative rating of /negative views about birth experience.

Review: Continuous support for women during childbirth

Comparison: 4 Continuous support versus usual care - policy about routine EFM

Outcome: 7 Negative rating of /negative views about birth experience

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Setting had routine EFM

Kennell 1991 47/212 71/200 14.4 % 0.62 [ 0.46, 0.85 ]

Dickinson 2002 75/499 74/493 16.1 % 1.00 [ 0.74, 1.35 ]

Hodnett 2002 96/2818 117/2751 20.2 % 0.80 [ 0.61, 1.04 ]

Campbell 2006 95/229 197/265 49.3 % 0.56 [ 0.47, 0.66 ]

Subtotal (95% CI) 3758 3709 100.0 % 0.67 [ 0.60, 0.76 ]

Total events: 313 (Continuous support), 459 (Usual care)

Heterogeneity: Chi2 = 13.50, df = 3 (P = 0.004); I2 =78%

Test for overall effect: Z = 6.59 (P < 0.00001)

2 Setting did not have routine EFM

Hofmeyr 1991 38/92 73/97 19.5 % 0.55 [ 0.42, 0.72 ]

Langer 1998 98/361 129/363 29.6 % 0.76 [ 0.61, 0.95 ]

Bruggemann 2007 7/105 17/107 2.0 % 0.42 [ 0.18, 0.97 ]

Morhason-Bello 2009 108/293 196/292 48.9 % 0.55 [ 0.46, 0.65 ]

Subtotal (95% CI) 851 859 100.0 % 0.60 [ 0.53, 0.68 ]

Total events: 251 (Continuous support), 415 (Usual care)

Heterogeneity: Chi2 = 6.85, df = 3 (P = 0.08); I2 =56%

Test for overall effect: Z = 8.36 (P < 0.00001)

3 Policy about routine EFM not known

Torres 1999 35/206 43/211 41.0 % 0.83 [ 0.56, 1.25 ]

Breart - Belgium 1992 24/119 30/121 29.7 % 0.81 [ 0.51, 1.31 ]

Breart - France 1992 30/656 35/664 29.4 % 0.87 [ 0.54, 1.40 ]

Subtotal (95% CI) 981 996 100.0 % 0.84 [ 0.65, 1.08 ]

Total events: 89 (Continuous support), 108 (Usual care)

Heterogeneity: Chi2 = 0.04, df = 2 (P = 0.98); I2 =0.0%

Test for overall effect: Z = 1.35 (P = 0.18)

Test for subgroup differences: Chi2 = 5.55, df = 2 (P = 0.06), I2 =64%

0.5 0.7 1 1.5 2

Favours support Favours usual care

88Continuous support for women during childbirth (Review)

Analysis 4.8. Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 8

Breastfeeding at 1-2 months postpartum.

Review: Continuous support for women during childbirth

Comparison: 4 Continuous support versus usual care - policy about routine EFM

Outcome: 8 Breastfeeding at 1-2 months postpartum

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Setting had routine EFM

Hodnett 2002 1312/2339 1283/2220 100.0 % 0.97 [ 0.92, 1.02 ]

Subtotal (95% CI) 2339 2220 100.0 % 0.97 [ 0.92, 1.02 ]

Total events: 1312 (Continuous support), 1283 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 1.16 (P = 0.25)

2 Setting did not have routine EFM

Hofmeyr 1991 58/74 51/75 14.5 % 1.15 [ 0.95, 1.40 ]

Langer 1998 266/334 247/321 85.5 % 1.04 [ 0.95, 1.12 ]

Subtotal (95% CI) 408 396 100.0 % 1.05 [ 0.98, 1.13 ]

Total events: 324 (Continuous support), 298 (Usual care)

Heterogeneity: Chi2 = 0.99, df = 1 (P = 0.32); I2 =0.0%

Test for overall effect: Z = 1.31 (P = 0.19)

Test for subgroup differences: Chi2 = 3.02, df = 1 (P = 0.08), I2 =67%

0.5 0.7 1 1.5 2

Favours support Favours usual care

89Continuous support for women during childbirth (Review)

Analysis 5.1. Comparison 5 Continuous support versus usual care - variations in provider characteristics,

Outcome 1 Any analgesia/anaesthesia.

Review: Continuous support for women during childbirth

Comparison: 5 Continuous support versus usual care - variations in provider characteristics

Outcome: 1 Any analgesia/anaesthesia

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Support people were hospital staff

Hodnett 2002 3077/3454 3159/3461 96.1 % 0.98 [ 0.96, 0.99 ]

Gagnon 1997 141/209 142/204 1.4 % 0.97 [ 0.85, 1.10 ]

Breart - Belgium 1992 55/133 62/131 0.3 % 0.87 [ 0.67, 1.15 ]

Breart - France 1992 281/656 319/664 1.7 % 0.89 [ 0.79, 1.00 ]

Hemminki 1990a 25/41 23/38 0.2 % 1.01 [ 0.71, 1.44 ]

Hemminki 1990b 45/81 52/80 0.4 % 0.85 [ 0.66, 1.10 ]

Subtotal (95% CI) 4574 4578 100.0 % 0.97 [ 0.96, 0.99 ]

Total events: 3624 (Continuous support), 3757 (Usual care)

Heterogeneity: Chi2 = 3.88, df = 5 (P = 0.57); I2 =0.0%

Test for overall effect: Z = 3.42 (P = 0.00062)

2 Support people were not hospital staff and not chosen by woman

Langer 1998 295/361 302/363 86.0 % 0.98 [ 0.92, 1.05 ]

Hofmeyr 1991 11/92 15/97 0.7 % 0.77 [ 0.37, 1.59 ]

Kennell 1991 93/212 150/200 13.1 % 0.58 [ 0.49, 0.69 ]

Klaus 1986 2/186 10/279 0.2 % 0.30 [ 0.07, 1.35 ]

Subtotal (95% CI) 851 939 100.0 % 0.91 [ 0.86, 0.97 ]

Total events: 401 (Continuous support), 477 (Usual care)

Heterogeneity: Chi2 = 32.58, df = 3 (P<0.00001); I2 =91%

Test for overall effect: Z = 2.82 (P = 0.0048)

3 Support people were not hospital staff and were chosen by woman

Morhason-Bello 2009 84/293 89/292 6.7 % 0.94 [ 0.73, 1.21 ]

Campbell 2006 247/300 260/300 88.7 % 0.95 [ 0.89, 1.02 ]

Madi 1999 28/53 41/56 4.7 % 0.72 [ 0.53, 0.97 ]

Subtotal (95% CI) 646 648 100.0 % 0.94 [ 0.88, 1.00 ]

Total events: 359 (Continuous support), 390 (Usual care)

Heterogeneity: Chi2 = 3.07, df = 2 (P = 0.21); I2 =35%

Test for overall effect: Z = 1.96 (P = 0.050)

Test for subgroup differences: Chi2 = 4.76, df = 2 (P = 0.09), I2 =58%

0.5 0.7 1 1.5 2

Favours support Favours usual care

90Continuous support for women during childbirth (Review)

Analysis 5.2. Comparison 5 Continuous support versus usual care - variations in provider characteristics,

Outcome 2 Synthetic oxytocin during labour.

Review: Continuous support for women during childbirth

Comparison: 5 Continuous support versus usual care - variations in provider characteristics

Outcome: 2 Synthetic oxytocin during labour

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Support people were hospital staff

Kashanian 2010 11/50 19/50 0.6 % 0.58 [ 0.31, 1.09 ]

Hodnett 2002 1040/3454 942/3461 40.9 % 1.11 [ 1.03, 1.19 ]

Gagnon 1997 82/209 96/204 4.6 % 0.83 [ 0.67, 1.04 ]

Breart - Belgium 1992 55/132 64/129 3.2 % 0.84 [ 0.64, 1.10 ]

Breart - France 1992 383/654 371/666 26.0 % 1.05 [ 0.96, 1.15 ]

Breart - Greece 1992 224/287 193/265 24.8 % 1.07 [ 0.97, 1.18 ]

Subtotal (95% CI) 4786 4775 100.0 % 1.06 [ 1.01, 1.11 ]

Total events: 1795 (Continuous support), 1685 (Usual care)

Heterogeneity: Chi2 = 12.25, df = 5 (P = 0.03); I2 =59%

Test for overall effect: Z = 2.24 (P = 0.025)

2 Support people were not hospital staff and not chosen by woman

Hofmeyr 1991 16/92 17/97 25.7 % 0.99 [ 0.53, 1.85 ]

Kennell 1991 36/212 46/200 64.7 % 0.74 [ 0.50, 1.09 ]

Klaus 1986 4/168 37/249 9.6 % 0.16 [ 0.06, 0.44 ]

Subtotal (95% CI) 472 546 100.0 % 0.69 [ 0.50, 0.94 ]

Total events: 56 (Continuous support), 100 (Usual care)

Heterogeneity: Chi2 = 9.42, df = 2 (P = 0.01); I2 =79%

Test for overall effect: Z = 2.34 (P = 0.020)

3 Support people were not hospital staff and were chosen by woman

Morhason-Bello 2009 51/293 56/292 0.5 % 0.91 [ 0.64, 1.28 ]

Bruggemann 2007 104/105 107/107 91.0 % 0.99 [ 0.96, 1.02 ]

Campbell 2006 133/291 144/295 2.1 % 0.94 [ 0.79, 1.11 ]

Torres 1999 167/217 172/218 6.2 % 0.98 [ 0.88, 1.08 ]

Madi 1999 7/53 17/56 0.1 % 0.44 [ 0.20, 0.96 ]

Subtotal (95% CI) 959 968 100.0 % 0.99 [ 0.96, 1.01 ]

Total events: 462 (Continuous support), 496 (Usual care)

Heterogeneity: Chi2 = 4.78, df = 4 (P = 0.31); I2 =16%

Test for overall effect: Z = 1.02 (P = 0.31)

Test for subgroup differences: Chi2 = 11.51, df = 2 (P = 0.00), I2 =83%

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

91Continuous support for women during childbirth (Review)

Analysis 5.3. Comparison 5 Continuous support versus usual care - variations in provider characteristics,

Outcome 3 Spontaneous vaginal birth.

Review: Continuous support for women during childbirth

Comparison: 5 Continuous support versus usual care - variations in provider characteristics

Outcome: 3 Spontaneous vaginal birth

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Support people were hospital staff

Kashanian 2010 46/50 38/50 1.8 % 1.21 [ 1.02, 1.44 ]

Hodnett 2002 2481/3454 2463/3461 64.5 % 1.01 [ 0.98, 1.04 ]

Dickinson 2002 280/499 239/493 4.0 % 1.16 [ 1.03, 1.30 ]

Gagnon 1997 132/209 127/204 2.6 % 1.01 [ 0.87, 1.18 ]

Breart - Belgium 1992 97/133 87/131 2.2 % 1.10 [ 0.94, 1.29 ]

Breart - France 1992 453/656 424/664 9.7 % 1.08 [ 1.00, 1.17 ]

Breart - Greece 1992 215/295 194/274 5.4 % 1.03 [ 0.93, 1.14 ]

Hemminki 1990a 38/41 34/38 3.0 % 1.04 [ 0.90, 1.19 ]

Hemminki 1990b 76/81 72/80 6.8 % 1.04 [ 0.95, 1.14 ]

Subtotal (95% CI) 5418 5395 100.0 % 1.03 [ 1.01, 1.06 ]

Total events: 3818 (Continuous support), 3678 (Usual care)

Heterogeneity: Chi2 = 10.94, df = 8 (P = 0.21); I2 =27%

Test for overall effect: Z = 2.53 (P = 0.011)

2 Support people were not hospital staff and not chosen by woman

Langer 1998 264/361 254/363 25.5 % 1.05 [ 0.95, 1.15 ]

Hofmeyr 1991 74/92 76/97 10.2 % 1.03 [ 0.89, 1.19 ]

Kennell 1991 179/212 137/200 17.7 % 1.23 [ 1.10, 1.38 ]

Hodnett 1989 47/72 42/73 3.2 % 1.13 [ 0.88, 1.47 ]

Klaus 1986 172/186 225/279 43.3 % 1.15 [ 1.07, 1.23 ]

Subtotal (95% CI) 923 1012 100.0 % 1.12 [ 1.07, 1.17 ]

Total events: 736 (Continuous support), 734 (Usual care)

Heterogeneity: Chi2 = 6.89, df = 4 (P = 0.14); I2 =42%

Test for overall effect: Z = 4.82 (P < 0.00001)

3 Support people were not hospital staff and were chosen by woman

Bruggemann 2007 41/105 38/107 4.7 % 1.10 [ 0.78, 1.56 ]

Campbell 2006 223/300 220/300 63.5 % 1.01 [ 0.92, 1.11 ]

Madi 1999 48/53 40/56 16.5 % 1.27 [ 1.05, 1.53 ]

0.5 0.7 1 1.5 2

Favours usual care Favours support

(Continued . . . )

92Continuous support for women during childbirth (Review)

(. . . Continued) Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

Torres 1999 110/217 101/218 15.3 % 1.09 [ 0.90, 1.33 ]

Subtotal (95% CI) 675 681 100.0 % 1.07 [ 0.99, 1.15 ]

Total events: 422 (Continuous support), 399 (Usual care)

Heterogeneity: Chi2 = 4.47, df = 3 (P = 0.21); I2 =33%

Test for overall effect: Z = 1.70 (P = 0.089)

Test for subgroup differences: Chi2 = 10.00, df = 2 (P = 0.01), I2 =80%

0.5 0.7 1 1.5 2

Favours usual care Favours support

Analysis 5.4. Comparison 5 Continuous support versus usual care - variations in provider characteristics,

Outcome 4 Caesarean birth.

Review: Continuous support for women during childbirth

Comparison: 5 Continuous support versus usual care - variations in provider characteristics

Outcome: 4 Caesarean birth

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Support people were hospital staff

Breart - Greece 1992 30/282 34/263 5.0 % 0.82 [ 0.52, 1.31 ]

Breart - Belgium 1992 5/133 5/129 0.7 % 0.97 [ 0.29, 3.27 ]

Breart - France 1992 40/654 36/665 5.6 % 1.13 [ 0.73, 1.75 ]

Gagnon 1997 29/209 33/204 5.1 % 0.86 [ 0.54, 1.36 ]

Hemminki 1990b 2/81 3/80 0.3 % 0.66 [ 0.11, 3.84 ]

Hemminki 1990a 0/41 3/38 0.1 % 0.13 [ 0.01, 2.49 ]

Dickinson 2002 71/499 85/493 12.8 % 0.83 [ 0.62, 1.10 ]

Hodnett 2002 432/3454 437/3461 69.3 % 0.99 [ 0.87, 1.12 ]

Kashanian 2010 4/50 12/50 1.0 % 0.33 [ 0.12, 0.96 ]

Subtotal (95% CI) 5403 5383 100.0 % 0.95 [ 0.85, 1.05 ]

Total events: 613 (Continuous support), 648 (Usual care)

Heterogeneity: Chi2 = 8.14, df = 8 (P = 0.42); I2 =2%

Test for overall effect: Z = 1.07 (P = 0.28)

0.02 0.1 1 10 50

Favours support Favours usual care

(Continued . . . )

93Continuous support for women during childbirth (Review)

(. . . Continued) Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

2 Support people were not hospital staff and not chosen by woman

Langer 1998 85/357 97/356 50.3 % 0.87 [ 0.68, 1.12 ]

Hofmeyr 1991 11/92 14/97 5.9 % 0.83 [ 0.40, 1.73 ]

Kennell 1991 17/212 26/200 9.5 % 0.62 [ 0.35, 1.10 ]

Hodnett 1989 12/72 13/73 6.2 % 0.94 [ 0.46, 1.91 ]

Cogan 1988 2/20 1/14 0.6 % 1.40 [ 0.14, 13.98 ]

Klaus 1986 12/168 46/249 8.7 % 0.39 [ 0.21, 0.71 ]

McGrath 2008 30/224 49/196 18.8 % 0.54 [ 0.35, 0.81 ]

Subtotal (95% CI) 1145 1185 100.0 % 0.72 [ 0.60, 0.86 ]

Total events: 169 (Continuous support), 246 (Usual care)

Heterogeneity: Chi2 = 9.57, df = 6 (P = 0.14); I2 =37%

Test for overall effect: Z = 3.59 (P = 0.00033)

3 Support people were not hospital staff and were chosen by woman

Morhason-Bello 2009 27/305 68/298 23.1 % 0.39 [ 0.26, 0.59 ]

Bruggemann 2007 11/105 12/107 6.7 % 0.93 [ 0.43, 2.02 ]

Campbell 2006 55/291 53/295 34.4 % 1.05 [ 0.75, 1.48 ]

Madi 1999 3/53 7/56 2.4 % 0.45 [ 0.12, 1.66 ]

Torres 1999 54/217 46/218 33.5 % 1.18 [ 0.83, 1.67 ]

Subtotal (95% CI) 971 974 100.0 % 0.84 [ 0.69, 1.03 ]

Total events: 150 (Continuous support), 186 (Usual care)

Heterogeneity: Chi2 = 19.55, df = 4 (P = 0.00061); I2 =80%

Test for overall effect: Z = 1.66 (P = 0.098)

Test for subgroup differences: Chi2 = 6.75, df = 2 (P = 0.03), I2 =70%

0.02 0.1 1 10 50

Favours support Favours usual care

94Continuous support for women during childbirth (Review)

Analysis 5.5. Comparison 5 Continuous support versus usual care - variations in provider characteristics,

Outcome 5 Admission to special care nursery.

Review: Continuous support for women during childbirth

Comparison: 5 Continuous support versus usual care - variations in provider characteristics

Outcome: 5 Admission to special care nursery

Study or subgroup Continuous support Usual care Risk Ratio Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Support people were hospital staff

Hodnett 2002 246/3454 254/3461 0.97 [ 0.82, 1.15 ]

Kashanian 2010 0/50 0/50 0.0 [ 0.0, 0.0 ]

Gagnon 1997 15/209 10/204 1.46 [ 0.67, 3.18 ]

Subtotal (95% CI) 3713 3715 0.99 [ 0.84, 1.17 ]

Total events: 261 (Continuous support), 264 (Usual care)

Heterogeneity: Chi2 = 1.03, df = 1 (P = 0.31); I2 =3%

Test for overall effect: Z = 0.14 (P = 0.89)

2 Support people were not hospital staff and not chosen by woman

Klaus 1986 3/168 17/249 0.26 [ 0.08, 0.88 ]

Kennell 1991 69/212 71/200 0.92 [ 0.70, 1.20 ]

Subtotal (95% CI) 380 449 0.86 [ 0.66, 1.12 ]

Total events: 72 (Continuous support), 88 (Usual care)

Heterogeneity: Chi2 = 3.92, df = 1 (P = 0.05); I2 =75%

Test for overall effect: Z = 1.09 (P = 0.28)

3 Support people were not hospital staff and were chosen by woman

Bruggemann 2007 5/105 6/107 0.85 [ 0.27, 2.70 ]

Torres 1999 12/215 6/213 1.98 [ 0.76, 5.18 ]

Subtotal (95% CI) 320 320 1.40 [ 0.67, 2.93 ]

Total events: 17 (Continuous support), 12 (Usual care)

Heterogeneity: Chi2 = 1.22, df = 1 (P = 0.27); I2 =18%

Test for overall effect: Z = 0.89 (P = 0.37)

Test for subgroup differences: Chi2 = 1.74, df = 2 (P = 0.42), I2 =0.0%

0.1 0.2 0.5 1 2 5 10

Favours support Favours usual care

95Continuous support for women during childbirth (Review)

Analysis 5.6. Comparison 5 Continuous support versus usual care - variations in provider characteristics,

Outcome 6 Postpartum depression.

Review: Continuous support for women during childbirth

Comparison: 5 Continuous support versus usual care - variations in provider characteristics

Outcome: 6 Postpartum depression

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Support people were hospital staff

Hodnett 2002 245/2816 277/2751 100.0 % 0.86 [ 0.73, 1.02 ]

Subtotal (95% CI) 2816 2751 100.0 % 0.86 [ 0.73, 1.02 ]

Total events: 245 (Continuous support), 277 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 1.75 (P = 0.080)

2 Support people were not hospital staff and not chosen by woman

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]

Total events: 0 (Continuous support), 0 (Usual care)

Heterogeneity: not applicable

Test for overall effect: not applicable

3 Support people were not hospital staff and were chosen by woman

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]

Total events: 0 (Continuous support), 0 (Usual care)

Heterogeneity: not applicable

Test for overall effect: not applicable

0.05 0.2 1 5 20

Favours support Favours usual care

96Continuous support for women during childbirth (Review)

Analysis 5.7. Comparison 5 Continuous support versus usual care - variations in provider characteristics,

Outcome 7 Negative rating of/negative feelings about birth experience.

Review: Continuous support for women during childbirth

Comparison: 5 Continuous support versus usual care - variations in provider characteristics

Outcome: 7 Negative rating of/negative feelings about birth experience

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Support people were hospital staff

Hodnett 2002 96/2818 117/2751 41.4 % 0.80 [ 0.61, 1.04 ]

Dickinson 2002 75/499 74/493 33.1 % 1.00 [ 0.74, 1.35 ]

Breart - Belgium 1992 24/133 30/131 12.6 % 0.79 [ 0.49, 1.27 ]

Breart - France 1992 30/656 35/664 12.8 % 0.87 [ 0.54, 1.40 ]

Subtotal (95% CI) 4106 4039 100.0 % 0.87 [ 0.73, 1.03 ]

Total events: 225 (Continuous support), 256 (Usual care)

Heterogeneity: Chi2 = 1.40, df = 3 (P = 0.70); I2 =0.0%

Test for overall effect: Z = 1.61 (P = 0.11)

2 Support people were not hospital staff and not chosen by woman

Langer 1998 98/361 129/363 46.6 % 0.76 [ 0.61, 0.95 ]

Hofmeyr 1991 38/92 73/97 30.8 % 0.55 [ 0.42, 0.72 ]

Kennell 1991 47/212 71/200 22.6 % 0.62 [ 0.46, 0.85 ]

Subtotal (95% CI) 665 660 100.0 % 0.66 [ 0.57, 0.77 ]

Total events: 183 (Continuous support), 273 (Usual care)

Heterogeneity: Chi2 = 3.64, df = 2 (P = 0.16); I2 =45%

Test for overall effect: Z = 5.47 (P < 0.00001)

3 Support people were not hospital staff and were chosen by woman

Morhason-Bello 2009 108/293 196/292 44.9 % 0.55 [ 0.46, 0.65 ]

Bruggemann 2007 7/105 17/107 1.8 % 0.42 [ 0.18, 0.97 ]

Campbell 2006 95/229 197/265 45.3 % 0.56 [ 0.47, 0.66 ]

Torres 1999 35/206 43/211 8.0 % 0.83 [ 0.56, 1.25 ]

Subtotal (95% CI) 833 875 100.0 % 0.57 [ 0.51, 0.64 ]

Total events: 245 (Continuous support), 453 (Usual care)

Heterogeneity: Chi2 = 4.18, df = 3 (P = 0.24); I2 =28%

Test for overall effect: Z = 9.70 (P < 0.00001)

Test for subgroup differences: Chi2 = 16.47, df = 2 (P = 0.00), I2 =88%

0.5 0.7 1 1.5 2

Favours support Favours usual care

97Continuous support for women during childbirth (Review)

Analysis 5.8. Comparison 5 Continuous support versus usual care - variations in provider characteristics,

Outcome 8 Breastfeeding at 1-2 months postpartum.

Review: Continuous support for women during childbirth

Comparison: 5 Continuous support versus usual care - variations in provider characteristics

Outcome: 8 Breastfeeding at 1-2 months postpartum

Study or subgroup Continuous support Usual care Risk Ratio Weight Risk Ratio

n/N n/N IV,Fixed,95% CI IV,Fixed,95% CI

1 Support people were hospital staff

Hodnett 2002 1312/2339 1283/2220 100.0 % 0.97 [ 0.92, 1.02 ]

Subtotal (95% CI) 2339 2220 100.0 % 0.97 [ 0.92, 1.02 ]

Total events: 1312 (Continuous support), 1283 (Usual care)

Heterogeneity: not applicable

Test for overall effect: Z = 1.16 (P = 0.25)

2 Support people were not hospital staff and not chosen by woman

Langer 1998 266/334 247/321 85.5 % 1.04 [ 0.95, 1.12 ]

Hofmeyr 1991 58/74 51/75 14.5 % 1.15 [ 0.95, 1.40 ]

Subtotal (95% CI) 408 396 100.0 % 1.05 [ 0.98, 1.13 ]

Total events: 324 (Continuous support), 298 (Usual care)

Heterogeneity: Chi2 = 0.99, df = 1 (P = 0.32); I2 =0.0%

Test for overall effect: Z = 1.31 (P = 0.19)

3 Support people were not hospital staff and were chosen by woman

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]

Total events: 0 (Continuous support), 0 (Usual care)

Heterogeneity: not applicable

Test for overall effect: not applicable

Test for subgroup differences: Chi2 = 3.02, df = 1 (P = 0.08), I2 =67%

0.5 0.7 1 1.5 2

Favours support Favours usual care

W H A T ’ S N E W

Last assessed as up-to-date: 9 January 2011.

Date Event Description

31 December 2010 New search has been performed Search updated. We evaluated and added new trials. We obtained additional information from trial au- thors. Other revisions included numerous changes to bring the entire Review up-to-date in terms of cur- rent methodological guidelines. We altered the accept- able follow-up rate for long term outcomes, and we expanded the number of outcomes to be included in

98Continuous support for women during childbirth (Review)

(Continued)

the planned subgroup analyses.

25 October 2010 New citation required but conclusions have not changed

New author joined the review team to update the re- view.

H I S T O R Y

Protocol first published: Issue 3, 2002

Review first published: Issue 3, 2003

Date Event Description

12 May 2008 Amended Converted to new review format.

18 April 2007 New search has been performed Search updated in February 2007. Two new trials identified. We excluded one (Dalal 2006) and included the other (Campbell 2006). The Results section was updated accordingly. With the exception of the outcome of labour length, there were no substantive changes in results or conclusions of the Review. Mi- nor edits were made throughout. Additional text was added to the Discussion.

30 October 2006 New search has been performed Search updated. One ’awaiting assessment’ trial was assessed and included (Thomassen 2003).

C O N T R I B U T I O N S O F A U T H O R S

Ellen Hodnett wrote the initial draft of the protocol. Carol Sakala wrote the initial draft of the Discussion in the previous version of the Review. Simon Gates wrote the initial draft of the statistical methods and provided statistical advice for the Protocol and each update of the Review. Julie Weston entered the data for the current update. All review authors participated in all aspects of the preparation of the protocol and in writing the text of the Review. All authors participated in the update of the Review.

D E C L A R A T I O N S O F I N T E R E S T

Ellen Hodnett was the principal investigator for two labour support trials. Justus Hofmeyr was the principal investigator for one labour support trial. Julie Weston was the Trial Coordinator for the Hodnett 2002 trial.

99Continuous support for women during childbirth (Review)

S O U R C E S O F S U P P O R T

Internal sources

• University of Toronto, Canada. • University of the Witwatersrand, South Africa. • Fort Hare University, South Africa. • East London Hospital Complex, South Africa. • National Perinatal Epidemiology Unit, Oxford, UK. • Childbirth Connection (formerly Maternity Center Association), USA. • Warwick Clinical Trials Unit, University of Warwick, UK.

External sources

• No sources of support supplied

I N D E X T E R M S

Medical Subject Headings (MeSH)

∗Delivery, Obstetric [methods; nursing]; ∗Labor, Obstetric; Midwifery; Obstetrical Nursing; Perinatal Care [∗methods; standards]; Randomized Controlled Trials as Topic

MeSH check words

Female; Humans; Pregnancy

100Continuous support for women during childbirth (Review)