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First Draft of Evidence Synthesis and Conclusion

Evidence Synthesis

Description of Studies Collectively

Four of the

fifteen

randomized control trials were performed in the United States, three in

Israel, and two in Turkey, with additional locations of Nigeria, Singapore, India, France, Finland,

and Sri Lanka. All studies

clearly stated the number of patients included in each s

tudy group,

with

four

of the studies further separating the intervention and control groups by parity

(

nulliparous vs. multiparous

All of the studies included in this review were randomized

control

led trials which varied in sample size from smaller studies with 80 participants to large

studies involving 1,216 participants.

The studies randomized participants into groups using

various randomization techniques including block randomization and compute

generated

randomization.

The

population of the

participants

in all of the studies

was

term pregnant patients

undergoing

various methods of cervical ripening for

induction of labor.

The patients all had

singleton pregnancies in vertex presentation with in

tact amniotic membranes

and no previous

cesarean section

ll of the studies looked at the outcome of method of delivery (cesarean

delivery

vaginal birth)

. A

dditional outcomes studied included: the

intervention

active

labor

interval

the

intervention

delivery interval

, pain perception scores

, maternal/fetal infection

rates,

change in bishop score

, the need for additional induction methods,

the occurrence of uterine

hyperactivity,

and

complication

rates

during

induction, delivery, or pos

tpartum

Fetal outcomes

observed included: fetal weight, APGAR scores,

meconium

stained

amniotic fluid,

and

neonatal

ICU admission

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Various induction methods for cervical ripening were

studied

as interventions including

pharmacological

nonpharmacologica

l, and combination methods

. Pharmacological methods

studied included

differing

medication

doses

dosing regimens, formulation

s (tablets,

vaginal

inserts, vaginal gel

)

and routes of administration

(

vaginal, oral, buccal)

for the

following

medications

misoprostol and dinoprostone.

Additionally, one study assessed oxytocin infusion

as a pharmacologic

cervical ripening

method

Nonpharmacological or mechanical methods

studied included cervical ripening balloons including: foley balloon cathet

ers and cook’s double

balloon catheters (filled with various amounts of fluid,

for differing amounts of time,

with or

without traction)

Combination methods included: misoprostol

buccal or vaginal)

(

with foley

balloon catheter

dinoprostone vaginal inser

t with a foley

balloon

catheter

One study looked at

the combination of

dinoprostone vaginal insert with adjunctive sweeping of membranes.

Themes

and F

indings

Across Studies

Method

of Cervical Ripening: Mechanical and Pharmacological

Twelve of the fifteen studies

looked at

pharmacological methods of cervical ripening.

However, the dosages, routes of administration, formulations and frequencies varied between

studies. Five of the stu

dies looked at the effects of misoprostol, six focused on dinoprostone, and

one study evaluated the effects of oxytocin. However, the dosages, routes of administration,

formulations and frequencies varied between studies. For

example

, Aduloju et al. (2021)

studied

misoprostol dissolved

in water and consumed orally, while Gomez et al. (2021) studied

misoprostol pills administered both buccally and vaginally.

Eleven of the fifteen studies focused on mechanical methods of cervical ripening. Eight

studies eval

uated foley balloon catheters and four evaluated cook’s double balloon catheters.

However

, the balloons were filled with varying amounts of liquid, were left in for varying

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amounts of time, with or without traction. For example, Diguisto et al. (2021) focused on cook’s

double balloon catheters with each balloon filled with 80mL of fluid with no traction, while Al

Ibraheemi et al. (2018) studied cervical ripening with foley ca

theters filled with 30mL of fluid

with traction.

Two studies evaluated the of length of time the cervical ripening balloon was left

inserted. Bleicher et al. (2020) studied the removal of cook’s catheter after six hours vs. twelve

hours, while Wickramasing

he et al. (2020) compared cervical ripening with a foley balloon for

hours vs. 48 hours.

Five articles considered combination methods

of cervical ripening (pharmacological

with

mechanical).

One study evaluated misoprostol with a foley balloon vs. misop

rostol alone (Al

Ibraheemi et al., 2021), one study evaluated dinoprostone with a foley balloon vs. dinoprostone

alone

Eser et al., 2019), and two studies looked at dinoprostone with a foley balloon vs. a foley

(

balloon alone (Chowdhary et al., 2019; Edwar

ds et al., 2021).

While Gomez et al. (2021) looked

at buccal misoprostol combined with a foley balloon vs. vaginal misoprostol combined with a

foley balloon for cervical ripening.

Lastly, although not combining mechanical with

pharmacologic methods of induction,

Bhatia et al. (2021) studied the effects of dinoprostone

with adjunctive sweeping of membranes vs. dinoprostone alone.

Methods of Induction of Labor after Cervical Ripening

The methods and procedures for continuation of induction of labor after the process of

cervical ripening varied widely between studies. The variation in these methods makes it difficult

to compare results, as the differing methods used could impact the res

ults and outcomes of the

studies. For instance, if not spontaneously expelled, the time of removal of

the

cervical ripening

balloons varied greatly between studies. In some studies, cervical ripening balloons were

removed after 24 hours (Al

Ibraheemi et al

., 2018; Diguisto et al., 2021), after 12 hours

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(

Chowdhary et al., 2019; Edwards et al., 2021; Gomez et al., 2021), or after 18 hours (Barda et

al., 2018).

In eleven of the studies, if after cervical ripening, the patient was not in active labor,

intravenous oxytocin was initiated for augmentation and amniotomy was performed if feasible,

usually after the patient reached 3

cm dilation. Oxytocin protocols va

ried greatly according to

hospital policies. Additionally, some studies did not have set protocols for continuation of

induction of labor after cervical ripening, but instead further management of labor was left to the

discretion of the health care provide

r (Al

Ibraheemi et al., 2018; Edwards et al., 2021).

Alternatively, in some studies, i

f the intended cervical ripening agent did not have the intended

effects, an alternative method was offered according to unit protocol (Bleicher et al., 2020;

Wickramasin

ghe et al., 2020). Lastly, in the study conducted by Hokkila et al. (2019), if onset of

labor was not reached within a certain time frame

induction was continued by other methods

(

i.e., vaginal

‐

μg misoprostol tablets, balloon catheter, amniotomy or int

ravenous oxytocin).

conclusion

hen additional induction methods are

implemented

after the intended

cervical

ripening

protocol

potentially confounding variables are introduced and it becomes difficult to

compare outcomes.

Initiation of Induction

elivery Time Interval

Many of the studies evaluated the length of time it took for

patients

to have a vaginal

delivery after the initiation of induction of labor.

Ten

of the studies found statistically significant

results.

Four

studies

found that combination methods short

ed the time to delivery.

Ibraheemi et al. (2018)

found that t

ime to delivery was significantly shorter in the combined

misoprostol/Foley

balloon

group

: 15.0 (11.0

–

hours (median [interquartile range]) vs 19.0

21.8)

(14.0

–

27.3)

hours in the misoprostol

only group (P=.001).

Chowdhary et al. (2019) found that

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the mean induction to delivery interval was significantly lower in the combined

dinoprostone

gel/foley balloon group vs the foley balloon

only group (16 hours 16 minutes vs. 20 hours and

= .002).

minutes, p

Additionally, Eser et al. (2019) found that for nulliparous women, the

foley balloon and dinoprostone group was shown to be as

sociated with shorter duration from

induction to active stage of labor when compared to dinoprostone alone (1000 vs. 585 min, P <

0.001)

and to delivery (1386 vs. 1001 min, P < 0.001). Lastly, Edwards et al. (2021) found that

nulliparous

women

in the

combi

nation dinoprostone

and foley balloon

group were more likely to

birth within 24

hours

(

p = 0.002) and to deliver vaginally within 24hours

(p=0.02)

when

compared to the foley alone group,

without an increase in the rate of

cesarean section.

Overall,

ombina

tion methods of cervical ripening

shorten the induction to delivery time when compared

to a single induction method used alone.

Statistically significant pharmacological

results include the findings from

Diguisto et al.

(2021)

that

found the

time from cervical ripening to delivery was shorter in the pharmacological

dinoprostone group vs. the cook’s catheter cervical ripening group (23 hours versus 32 hours,

median difference 6.5 95% CI 5.0 to 7.9, p < 0.00

Additionally, Hokkila et al. (2019) found

that in the vaginal misoprostol group vs the oral misoprostol group, the median time to vaginal

delivery was shorter (24.5 hours vs 44.2 hours, P < 0.001).

Finally, Gomez et al. (2021)

compared buccal misoprost

ol with a foley balloon vs. vaginal misoprostol with a foley balloon.

The vaginal group achieved a faster median time to delivery than the buccal group (19.7 hours

for the vaginal route vs 24.1 hours for the buccal route; P<.001).

According to the studies

comparing routes of administration for misoprostol, vaginal misoprostol

was

associated with a

shorter induction to delivery time.

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Three articles had significant findings regarding

ook’s

double balloon

catheters for

cervical ripening.

Bleicher et al. (2020) compared removal of cook’s balloons at six and twelve

hours after insertion. The insertion

delivery interval was significantly shorter in the 6

hour

group for both nulliparous (25.6 hr vs 31.4 hr,

P=.04; mean difference 5.8, 95% CI 0.2

–

11.3)

and parous cohorts (18.06 hr vs 22.66 hr, P=.003; mean difference 4.7, 95% CI 1.6

–

7.7)

Solt et

al. (2021) compared cook’s double balloon catheters with foley balloons and found that the mean

interval from cat

heter withdrawal to delivery was shorter in the cook’s catheter group (14.6±12.3

and 8.6±5.4) than in the Foley catheter group (22.6±27.2 and 13.9±17.7), in both nulliparas and

multiparas (p=.05 and p=.03, respectively).

Lastly, Tülek et al. (2019) compare

d oxytocin and

cook’s catheters for cervical ripening for multiparous patients and found that the median time to

delivery was 9.45 hours in cervical ripening balloon group and 13.2 hours in the oxytocin group

(

p<0.001).

Cook’s catheters shortened the

induc

tion to delivery interval when compared to foley

balloons and oxytocin (for multiparous patients).

Discussion

Overall

indings

According to this review, there were no specific methods of induction of labor that were

associated with a decreased rate of cesarean

delivery

. Thirteen of the fifteen studies included in

this review found

no difference in the rate of cesarean deliverie

s w

hen comparing various

cervical ripening methods. Two studies found significant findings related to cesarean

delivery

rates for nulliparous patients. One study found that

the rate of

cesarean delivery

was significantly

lower

for nulliparous patients who rec

eived a foley cervical ripening balloon when compared to

the group who received dinoprostone tablets for induction of labor

.006)

(

Barda et al., 2018).

However, according to

a recent Cochrane analysis there was no significant difference in the rate

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cesarean section

when mechanical methods were compared to dinoprostone (Jozwiak et al.,

2012).

Additionally, Cook’s catheters were found to be associated with a lower cesarean

section

rate for nulliparous patients when compared with foley catheter balloons for labor induction

(

p =

.02)

(

Solt

et al.,

2021)

However, a recent systematic review and met

analysis that compared

double

balloon to single

balloon catheter for cervical ripening and labor induction found no

significant differences in cesarean delivery rate or vaginal delivery rate within 24 hours between

the two methods (Yang et al., 2017).

cording to this review, there are no evidence

based

methods for labor induction that are associated with a decreased risk of cesarean delivery.

Overall, the results

from this review

highlighted that

mechanical and pharmacological

combination methods (such

as misoprostol or dinoprostone with a cervical ripening balloon)

shorten the intervention

delivery time interval, when compared to one single cervical ripening

method alone, especially for nulliparous patients.

Additionally, when comparing route of

adm

inistration for misoprostol, vaginal misoprostol is associated with a shorter induction to

vaginal

delivery time when compared to oral and buccal administration.

Limitations

There were several limitations to this review. Although all studies were randomized

control trials, in all but one of the studies, participants were not blinded to the intervention.

Furthermore, p

roviders were

not

blinded to the intervention

in any of the

studies

In addition

patients were not separated by parity

in several of the studies

. If this had been the case,

possibly

the results

would

be different.

Importantly, it was difficult to compare study results because the

studies utilized different

medication doses, dosing regimens, formulations

and routes of

administration

Moreover, the studies involving cervical ripening balloons inflated them to

various

amounts (30mL to 80mL). A major limitation found in some of the studies was that

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several

patients

involved

did not

solely

receive their allocated

intervention

as a result of health

care provider preference

, but they were still included in the results.

For

instance, in one study

comparing different doses of misoprostol, providers used cervical ripening balloons as an

additional cervical ripening method in more than 20% of the cases (Pimentel et al., 2018).

Moreover

, the induction methods

utilized

after

the

cervical ripening

interventions

varied widely

between studies. This makes it even more challenging to compare findings and attribute

outcomes to cervical ripening methods alone.

When looking at individual studies, there were additional limitations. For in

stance, one

the studies was conducted in a low resource environment where dosing of medications may have

been inexact (

Aduloju

et al., 2

021)

Additionally, one article only studied patients after 41

weeks’ gestation, so results may not be

generalizable to other gestations

(

Diguisto

et al.,

2021)

Lastly, i

is difficult to directly compare induction of labor methods when there are so

many potentially confounding variables (

e.g.

the use of oxytocin, time of amniotomy for

augmentation

hospital policies, different dosing regimens

, pain medications, fetal heartrate

patterns, staffing/time constraints delaying treatment

)

and it is difficult to control

the

immeasurable variables in

labor

and birth

environment.

Therefore, it is difficult t

o draw

conclusions

and give practice recommendations

based on

the

review of the literature.

Summary and

Practice Recommendation

This review suggests that

there are no

definitive

methods of labor induction that

decrease

the rate

of cesarean

delivery.

Overall,

this review found that

combination methods of cervical

ripening (mechanical and pharmacologic)

were shown to

shorten the induction to delivery time

when compared to a single induction method used alone

, especially for nulliparous patient

Additionally, this review suggests that vaginal misoprostol may

shorten the

induction to delivery

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time when compared to oral and buccal

routes of administration

Despite the

availability of

numerous pharmacologic and mechanical methods, t

he results of t

his review do not

suggest

that

any one method of cervical ripening

should be chosen over another

, n

any one method

associated with

significantly

better

outcomes.

Therefore,

it is

challenging

determine

the best

interventions for labor induction

establish

an induction of labor algorithm.

Decisions

regarding the safest method of cervical ripening should be made

according to maternal and

obstetric indications.

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