Accepted Manuscript

Title: Risk of maternal, fetal and neonatal complications

associated with the use of the transcervical balloon catheter in
induction of labour: A systematic review

Authors: Jip S.M. Gommers, Milou Diederen, Chris

Wilkinson, Deborah Turnbull, Ben W.J. Mol

PII: S0301-2115(17)30445-1
DOI: http://dx.doi.org/10.1016/j.ejogrb.2017.09.014
Reference: EURO 10063

To appear in: EURO

Received date: 22-6-2017

Revised date: 13-9-2017
Accepted date: 14-9-2017

Please cite this article as: Gommers Jip SM, Diederen Milou, Wilkinson Chris, Turnbull
Deborah, Mol Ben W.J.Risk of maternal, fetal and neonatal complications associated
with the use of the transcervical balloon catheter in induction of labour: A systematic
review.European Journal of Obstetrics and Gynecology and Reproductive Biology
http://dx.doi.org/10.1016/j.ejogrb.2017.09.014

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Risk of maternal, fetal and neonatal complications associated with the use of the

transcervical balloon catheter in induction of labour: A systematic review.

Jip SM Gommers*a, Milou Diederen*a, Chris Wilkinsonb, Deborah Turnbullc, Ben WJ Mold

* Both authors contributed equally to this review

a Faculty of Health, Medicine and Life Sciences, Maastricht University, Universiteitssingel 60, 6229 ER

Maastricht, The Netherlands

b Department of Obstetrics and Gynaecology, Women’s and Children’s Hospital, 72 King William Road,

North Adelaide, South Australia 5006, Australia

c School of Psychology, The University of Adelaide, North Terrace, Adelaide, South Australia 5005,

Australia

d The Robinson Institute, School of Paediatrics and Reproductive Health, The University of Adelaide, 55

King William St. Road, North Adelaide, South Australia 5006, Australia

Conducted at: The University of Adelaide, North Terrace, Adelaide, South Australia 5005, Australia

Correspondence to: Jip SM Gommers. Postal Address: Faculty of Health, Medicine and Life Sciences,

Maastricht University, Universiteitssingel 60, 6229 ER Maastricht, The Netherlands. Telephone number

+31611321419. E-mail address: [email protected]

Abstract

Jip SM Gommers, Milou Diederen, Deborah Turnbull, Chris Wilkinson, Ben WJ Mol

Induction of labour is one of the most frequently applied obstetrical interventions globally. Many studies

have compared the use of balloon catheters with pharmacological agents. Although the safety of the

balloon catheter is often mentioned, little has been written about the total spectrum of maternal and fetal

morbidity associated with induction of labour using a balloon catheter. We evaluated the safety of labour

induction with a transcervical balloon catheter by conducting a literature review with pooled risk

assessments of the maternal, fetal and neonatal morbidity.

We searched Medline, EMBASE and CINAHL as well as the Cochrane database using the Keywords

‘induction of labour’, ‘cervical ripening’, ‘transcervical balloon’, ‘balloon catheter’ and ‘Foley balloon’. We

did not use language or date restrictions. Randomized and quasi-randomized controlled trials as well as

observational studies that contained original data on occurrence of maternal, fetal or neonatal morbidity

1
during induction of labour with the balloon catheter were included. Studies were excluded if the balloon

catheter was used concurrently with oxytocin and concurrently or consecutively with misoprostol,

dinoprostone or extra-amniotic saline infusion. Study selection and quality assessment was performed

by two authors independently using a standardized critical appraisal instrument. Outcomes were

reported as weighted mean rates.

We detected 84 articles reporting on 13,791 women. The overall risk of developing intrapartum maternal

infection was 11.3% (912 of 8,079 women), 3.3% (151 of 4,538 women) for postpartum maternal

infection and 4.6% (203 of 4,460 women) for neonatal infection. Uterine hypercontractility occurred in

2.7% (148 of 5,439) of the women. Uterine rupture after previous caesarean section occurred in 1.9%

of women (26 of 1,373), while other major maternal complications had an occurrence rate of < 1%. The

risk for developing minor maternal complications was < 2%. The risk of developing a non-reassuring

fetal heart rate was 10.8% (793 of 7,336 women), 10.1% (507 of 5,008 women) for fetal distress and

14.0% (460 of 3,295 women) for meconium stained liquor. Neonatal death occurred in 0.29% (6 of

2,058) of the deliveries and NICU admission in 7.2% (650 of 9,065 deliveries). This review shows that

labour induction with a balloon catheter is a safe intervention, with intrapartum maternal infection being

the only reasonable risk above 10%.

KEYWORDS Induction of labour; Transcervical balloon catheter; Adverse events; Safety; Systematic

review

2
INTRODUCTION

Ripening of the unfavourable cervix and induction of labour are worldwide commonly performed

obstetrical procedures. In well-resourced countries, labour is induced in 20-25% of all pregnancies. (1,

2) In case of an unripe cervix, induction of labour starts with cervical ripening for which a broad variety

of both pharmacological agents such as prostaglandins and mechanical methods such as the balloon

catheter are currently available. (2-4) Recent randomized controlled trials (RCTs) have shown that the

use of a balloon catheter has benefits over the use of both vaginal prostaglandin E2 gel and vaginal

misoprostol in terms of side-effects and safety profile with a comparable effectiveness, specifically with

respect to uterine hyperstimulation resulting in fetal distress and maternal haemorrhage. (4, 5) These

findings have led to the revival of the use of a balloon catheter for induction of labour.

Many studies report on a limited spectrum of adverse events with the use of the balloon catheter, but

they are often not powered to draw conclusions about its safety for clinical use. (6-8) Since the balloon

catheter is commonly used for labour induction, adequate information on its safety is of great

importance. After reviewing current literature, we have been unable to identify a systematic review that

includes an extensive pooled risk analysis of all possible maternal, fetal and neonatal complications

associated with the use of a balloon catheter for labour induction. We therefore aimed to conduct a

review with a pooled risk analysis in order to assess the safety of the transcervical balloon catheter for

labour induction.

3
METHODS

Data sources

We searched Medline, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL)

and the Cochrane electronic databases. Our search terms included ‘induction of labour’, ‘cervical

ripening’, ‘balloon catheter’, ‘Foley balloon’, and ‘transcervical balloon’, and were conducted in

consultation with an experienced medical librarian. We did not use date or language restrictions.

References from review articles were manually screened for relevant studies. Appendix S1 contains

detailed information on the search strategy.

Inclusion criteria

We included RCTs, quasi RCTs, cohort studies and case-controlled studies that compared the use of

the balloon catheter, regardless of volume and application of tension, with any other induction method

or spontaneous onset of labour. The balloon catheter could either have a single or double lumen. Studies

were eligible if they reported on maternal, fetal or neonatal outcomes as part of the primary or secondary

aim and contained original data on the occurrence of adverse events. Both studies on women with intact

membranes and premature rupture of membranes (PROM) were included. If an article expressly stated

the absence of adverse events in the studied population, it was also included. Studies using the balloon

induction concurrently or consecutive with another induction agent (misoprostol, prostaglandin E2,

oxytocin or extra-amniotic saline infusion) were excluded. We did include articles in which oxytocin or

artificial rupture of membranes (ARM) was administered for the augmentation of labour after

spontaneous expulsion or removal of the balloon catheter, since this procedure is often performed in

the process of labour induction. Furthermore, studies on induction for pregnancy termination and for

induction after intrauterine fetal death were excluded. Studies that reported on a prior attempt at labour

induction in the current pregnancy were also excluded. In addition, we excluded studies published as

abstracts only, or studies with missing full texts.

Study selection

Two authors (JG and MD) individually evaluated articles resulting from the search strategy by title and

abstract. After this the full text article was retrieved and a full-text assessment was performed

independently by the same two authors. Disagreements among investigators were discussed and

resolved by consensus.

4
To be included, a trial had to report on at least one of the following outcomes:

Infection maternal intrapartum infection (intrapartum infection in general/suspected, chorioamnionitis,

intrapartum fever >38˚C, use of antibiotics); postpartum maternal infection (postpartum infection in

general/suspected; puerperal fever >38˚C; endomyometritis; urinary tract infection; wound infection; use

of postpartum antibiotics); neonatal infection/sepsis (in general/suspected/proven, clinical sepsis,

neonatal fever >38˚C).

Abnormal uterine activity tachysystole; hyperstimulation; hypertonus; uterine hyperstimulation

syndrome; excessive uterine activity.

Hemorrhage intrapartum hemorrhage (bleeding after insertion, antepartum bleeding); postpartum

hemorrhage (unspecified volume, >500 mL, 1000 mL).

Major maternal uterine rupture/scar dehiscence; placental abruption; cord prolapse; malpresentation;

maternal death.

Minor maternal balloon rupture; displacement of the balloon; nausea/vomiting; pain/discomfort; voiding

problems; genital lacerations/birth canal injury; allergic reaction; unintended amniotomy.

Fetal non-reassuring fetal heart rate (in general/during ripening/as indication for CS/assisted deliveries,

fetal CTG abnormalities, fetal tachycardia, fetal bradycardia, late decelerations); suspected fetal distress

(unspecified/as indication for CS/assisted deliveries); meconium stained liquor; fetal death.

Neonatal NICU/ward admission; low Apgar score; low pH; meconium aspiration syndrome; asphyxia;

encephalopathy.

Both studies that provided a definition as well as studies that did not give definitions for the adverse

events were included.

Data extraction

Data were extracted independently by the two previously identified investigators from tables, graphs and

full text. If the use of the balloon catheter was compared with another intervention, the data for the

balloon catheter group only were extracted. The approach for subdividing the adverse events into minor

and major categories was made by the reviewers. A data extraction file was adapted based on the

Cochrane data extraction file. (9) Data were entered into a Microsoft Excel database and double

checked for accuracy by the two reviewers.

Quality assessment

5
The quality of selected studies was assessed independently by the two assessors using standardized

critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment

and Review Instrument (JBI-MAStARI). (10) Disagreements among the reviewers were discussed and

resolved after a consensus was reached.

Data analysis

The systematic review was registered in the PROSPERO International Prospective Register of

Systematic Reviews (registration number CRD42017058090) and conducted using the PRISMA (2009)

guidelines and checklist on Preferred Reporting Items for a Systematic review. (11) We subgrouped

each complication and calculated a weighted average with pooled risk assessment of the maternal, fetal

and neonatal morbidity.

RESULTS

A total of 585 studies were revealed after removal of duplicates. These studies were screened for

eligibility by title and abstract, after which 136 studies seemed eligible for full-text assessment (Fig. 1).

Of these 136 studies, 52 were excluded because: the full text was not traceable (n=22); the balloon

catheter was concurrently/consecutive used with other induction agents (n=8); the study was not yet

published and hence had not been subject to peer review (n=6); the indication for labour induction was

intra-uterine fetal death/early pregnancy termination (n=5); the authors did not report on adverse events

(n=4); no original data were used (n=3); data on adverse events were not distinguishable for the balloon

catheter as intervention (n=3); uncertain if all women received a Foley catheter before

amniotomy/oxytocin administration (n=1).

A total of 84 studies were therefore eligible and included in the review, of which 53 were RCTs, eight

were quasi RCTs, four were prospective cohort studies, 17 were retrospective cohort studies and two

were case-control studies (Table 1). These 84 studies reported on a total of 13,791 women who received

a balloon catheter for induction of labour, of which 12,769 received a single balloon catheter (SBC) and

1,022 a double balloon catheter (DBC). A total of 23 studies included women with a previous caesarean

section in their sample, while 10 studies included women with PROM before balloon induction. Of all

included participants in this review, 11% had a scarred uterus and 3% had PROM.

Intra- and postpartum infection

A total of 50 articles (8,079 women) reported on any form of intrapartum infection (Table 2). Of these,

43 articles only included women with intact membranes; the other seven articles included women with

6
intact membranes as well as PROM before balloon catheter insertion. The total PROM population was

5.1% (411 of 8,079 women). Intrapartum infection, mostly defined as intrapartum fever (>38C),

occurred among 11.3% (912 of 8,079 women). We were not able to assess intrapartum infection

amongst women with PROM because the outcome data on intrapartum infection in studies reporting on

both women with intact membranes as well as PROM were not distinguishable. In the 43 studies that

excluded women with PROM, intrapartum infection occurred among 9.3% (588 of 6,343 women).

There were 29 studies (4,538 women) that reported on postpartum maternal infection (Table 3),

including 115 women (2.5%, 3 studies) who had PROM before induction. In total, 151 of 4,538 (3.3%)

women developed any form of postpartum maternal infection. In the 26 studies including women without

PROM this was 144 (3.4% of 4199 women). Neonatal infection was reported in 20 articles (4460

women), including 106 (2.4%, 2 studies) women who had PROM. In total, 203 of 4460 neonates (4.6%)

developed an infection. In the 18 studies excluding women with PROM this occurred in 186 neonates

(4.5% of 4163 women).

Abnormal uterine activity

The pooled estimate for abnormal uterine activity included either tachysystole, hyperstimulation,

hypertonus, uterine hyperstimulation or excessive uterine activity (Table 4). Any form of uterine

contraction abnormalities occurred in 2.7% of women (148 of 5,439 women). However, it was not always

distinguishable if all these adverse events occurred in separate women. Tachysystole occurred in 45 of

2,278 women (2.0%).

Intra- and postpartum haemorrhage

Of all included articles, intra- and postpartum haemorrhage was reported in 14 and 33 studies

respectively (Table 5). Intrapartum haemorrhage was noted in 1.4% (36 of 2,600 women), and was

mostly due to bleeding after balloon insertion. Postpartum haemorrhage had an overall occurrence of

17.1% (993 of 5,819 women). There was >1000 mL blood loss in 408 women (12.4% of 3291 women);

> 500 mL blood loss in 471 women (24.5% of 1923 women); and in 114 women (6.5% of 1743 women)

the volume of blood loss was not specified.

Major maternal complications

There were 28 studies that reported on 26 women with uterine damage (4,329 women, 0.60%); 11 out

of 4255 women had uterine rupture and 15 out of 557 women had scar dehiscence. Uterine damage

only occurred amongst women with a previous caesarean section (CS) (26 of 1,373 women, 1.9%)

7
(Table 6). No events of uterine damage occurred among the 2,956 women without scarred uteri.

Placental abruption was diagnosed in 0.18% (6 of 3,408) of women and cord prolapse in 0.51% (9 of

1,762) of women, all receiving a single balloon. The occurrence of malpresentation was 0.19% (5 of

2,644 women), of which 2.0% (2 of 98 women) was after receiving a double balloon catheter. Only two

studies (800 women) explicitly reported that maternal death did not occur, while none of the other studies

reported any information on maternal death.

Minor maternal complications

Table 7 shows several minor complications. Balloon rupture occurred in 0.37% (1 of 269) of the women;

in 1.4% (19 of 1,368) the single balloon catheters were expulsed or displaced within one hour after

placement. Nausea/vomiting was reported 1.0% (4 of 398) of women. Voiding problems were reported

by 1.2% (5 of 432) of the women, while this rate was 2.8% (3 of 107) in women receiving a double

balloon catheter. Lacerations to the birth canal or genital area were reported in 1.5% (9 of 607) of women

(5 of 464 after single balloon; 4 of 143 after double balloon catheter). An allergic reaction to the balloon

occurred in 0.15% (2 of 1,332) of women, while unintended amniotomy at insertion happened in 0.43%

(2 of 467) of women. Pain or discomfort was reported in 24 articles; in 18 of these articles a single

balloon was used and in eight articles a double balloon catheter was inserted. Because these data were

often given as a mean of the cohort rather than an occurrence rate, we were not able to translate them

into our pooled risk analysis.

Fetal complications

A total of 38 studies reported on fetal heart rate abnormalities, which occurred in 10.8% (793 of 7,336)

of women (Table 8). Suspected fetal distress, mostly reported as an indication for a caesarean section,

was seen in 10.1% (507 of 5,008) of women. Furthermore, out of 3,295 women, meconium stained liquor

occurred in 14.0% (460) of women. Stillbirth, only explicitly reported on by only four studies covering

2,608 women, did not occur.

Neonatal complications

NICU admission occurred in 7.2% (650 of 9,065) of neonates and neonatal ward admission in 18.1%

(718 of 3,960) of neonates (Table 9). Asphyxia occurred in 1.0% (20 of 1,940) of neonates, and was

almost always an indication for NICU admission. Only two studies reported specifically on

encephalopathy which occurred in 0.48% (1 of 208) of the deliveries. Meconium aspiration syndrome

8
occurred in 1.1% (21 of 1,862) of deliveries. Apgar score <7 after 1 minute and 5 minutes occurred in

7.0% (302 of 4,297) and 2.0% (200 of 10,044) of the neonates respectively. Low cord pH, defined as a

pH <7.10, occurred in 3.2% (159 of 4,938) of the neonates.

In total, six (0.29% of 2,058 women) neonatal deaths occurred. Three of these were described in a

recent trial (12); two neonates died because of lethal congenital malformations diagnosed after delivery

and one baby died because of asphyxia. In this woman labour was induced because of polyhydramnios

and gestational diabetes. An emergency CS was performed because of fetal bradycardia after

amniotomy. The neonate (Apgar scores 1/0/1, cord pH 6.99, base excess -16) was admitted to the NICU

for whole-body cooling. An MRI showed severe brain damage after which treatment was stopped and

the baby died. No cause for asphyxia was found.

Another RCT (13) comparing balloon volumes in women with a previous CS reported one neonatal

death in their 80 mL Foley catheter group. The woman had uterine rupture and her baby developed

hypoxic encephalopathy. A cohort study (14) using the Foley catheter for induction after CS reported

two perinatal deaths. In the first case, the woman (G5P4) was induced because of previous stillbirth.

Low-dose oxytocin was administered 24 hours after Foley catheter insertion and three hours later an

emergency CS was performed because of acute fetal distress with fetal bradycardia. Uterine rupture

with fetal expulsion to the abdominal cavity was seen. The neonate (Apgar scores 1/3/4) was admitted

to the NICU with severe perinatal asphyxia and died of neurologic complications. In the second case,

rupture of the vasa praevia leading to neonatal death occurred after artificial rupture of membranes with

a scalp electrode for fetal monitoring.

COMMENT

This systematic review evaluated the safety of induction of labour with a transcervical balloon catheter

by addressing a wide range of potential adverse events using a pooled risk assessment. The overall

risk of maternal infection was 11% and 3.3% for the intrapartum and postpartum periods respectively.

The risk of neonatal infection/sepsis was 4.6%. Uterine contraction abnormalities occurred in 2.7% of

the women. The risk for non-reassuring fetal heart rate and fetal distress was 11% and 10% respectively,

with an overall risk of meconium stained liquor of 14%. A total of 2% of women with a scarred uterus

experienced uterine rupture and the risk for developing other major and minor maternal complications

9
was very low (<1% and <2% respectively). Severe neonatal complications, neonatal death and NICU

admission occurred in 0.29% and 7.2% of the women respectively.

STRENGTHS AND LIMITATIONS

The broad spectrum of all adverse events addressed in this review provides the most comprehensive

safety profile of the use of the balloon catheter for cervical ripening yet published. The inclusion of 84

studies with a total of 13,791 women makes our pooled risk assessment highly valid. We did not limit

our search to English published articles only, resulting in more complete information gathering and less

bias. In addition, we subgrouped all possible outcomes in order to portray our results in the most

homogenous way possible. Furthermore, apart from RCTs, we considered observational studies

appropriate to review since they can detect rare adverse events due to their larger sample size. (6-8)

To prevent selection bias, we excluded descriptive studies, case-series and case reports. Since the data

outcomes were derived from divergent sources with different study designs, we chose to perform a

pooled risk analysis rather than combining them in a meta-analysis. (7) A limitation of this review is that

assessment of the timing of the occurrence of a complication in the complete process of labour induction

was not always possible, making it difficult to assess the extent to which the ripening process itself was

the cause of the adverse event. In addition, the lack of standardized ‘core’ outcome definitions provided

in the included studies made the available data somewhat heterogenic, thus hampering pooling. (15,

16) Finally the inevitable variability in obstetrical decision making and hospital protocols in terms of

balloon types, sizes and volumes, application of tension, amount of time for cervical ripening and

oxytocin administration resulted in certain heterogeneity.

INTERPRETATION

The risk of infection with the use of the balloon catheter for labour induction remains a topic of debate.

A recently published meta-analysis evaluating the Foley catheter as a source of infection showed pooled

risks for maternal infections of 8.8%, chorioamnionitis 7.2%, endometritis 3.8% and neonatal infections

3.2% (17). The overall intrapartum infection rates in this review included chorioamnionitis, which might

have increased our reported rate. In contrast, we found a lower rate of endomyometritis which could be

explained by our larger, more generalizable study population. Our pooled results on neonatal infection

were slightly higher which was unexpected since we used similar definitions for neonatal infection.

10
Differences in inclusion and exclusion criteria could explain this difference as we included observational

studies but excluded concurrent use of the balloon catheter with another induction agent. Importantly,

direct comparisons of infection rates after balloon and prostaglandin use do not point to an increased

infection risk.

Another meta-analysis (18) compared the Foley catheter with misoprostol and dinoprostone and

suggested that the Foley catheter was the least likely of all three to cause uterine hyperstimulation with

FHR changes. The occurrence rate of 1.3% in that meta-analysis is lower than our overall pooled

estimates of uterine contraction abnormalities as well as our findings on hyperstimulation. A possible

explanation is that hyperstimulation was not necessarily combined with FHR changes in our review,

since we analyzed fetal heart rate abnormalities separately. Another recent systematic review on balloon

catheter induction after a previous caesarean section (19) found that 1.2% of the women had uterine

rupture (17 uterine ruptures, 1 scar dehiscence). Our findings indicated a slightly higher prevalence,

possibly because we also considered scar dehiscence without uterine rupture as uterine damage. Thus,

our outcome on only uterine rupture was slightly lower.

In terms of effectiveness, the balloon catheter has been compared with a variety of different induction

agents of which vaginal prostaglandin E2, vaginal misoprostol and oral misoprostol are commonly used

alternatives. When the Foley catheter was compared to vaginal prostaglandin E2, Jozwiak et al. (4)

found no difference in CS rate and vaginal instrumental deliveries with more caesarean sections due to

failure of progress in the Foley group but less for fetal distress. Ghezzi et al. (20) found lower CS rates

in the Foley group with similar insertion-to-delivery intervals and deliveries within 12 hours in both

groups. Ten Eikelder et al. (12) compared oral misoprostol with the Foley catheter and found that

misoprostol was not inferior to Foley catheter. When it comes to vaginal misoprostol versus Foley

balloon, Sciscione et al. (21) concluded that both interventions are equivalent with higher rates of

hyperstimulation and meconium passage for vaginal misoprostol. Chen et al. (18) found that vaginal

misoprostol compared to the other agents was the most effective intervention by significantly increasing

the number of vaginal deliveries within 24 hours. They found the lowest CS rates with oral misoprostol

but higher rates of hyperstimulation when compared with the Foley group. Another recent meta-analysis

(5) compared the Foley catheter with oral and vaginal misoprostol using total cesarean delivery rate,

cesarean delivery for failure to progress first stage and total vaginal instrumental deliveries as main

outcomes. They found comparable caesarean delivery rates between Foley catheter and oral/vaginal

11
misoprostol with fewer caesarean deliveries for non-reassuring fetal heart rate and suspected fetal

distress in the Foley group, but more caesarean sections due to nonprogressive labour. The authors

questioned the primary outcome ‘vaginal delivery not achieved within 24 hours’, stating that a fast

delivery does not necessarily have to be associated with a safe and effective delivery. Therefore they

suggest that the primary outcome measurements for effectiveness should be adjusted.

CONCLUSION

This review shows clinically significant risks associated with the process of induction of labour with a

balloon catheter and provides health care workers with the most complete safety profile possible from

the current literature which can be useful for clinical decision making as well as for obtaining informed

consent. In terms of future research, we recommend use of predefined standardized core outcomes in

order to ensure consistent synthesis of evidence by providing more homogeneous data and minimizing

bias. (8, 22) Clinically, induction of labour with a balloon catheter appears to be an effective, appropriate

and safe intervention. Clinical practitioners should be aware of the risk of developing maternal

intrapartum infection that we estimated at 11%. Nonetheless, this information is reassuring for the

routine use of balloon catheter in clinical practice.

12
ACKNOWLEGDEMENTS

We would like to thank Michael Draper, Medical Librarian, for his contribution to our search strategy.

BWM is supported by a NHMRC Practitioner Fellowship (GNT1082548).

DISCLOSURE OF INTEREST

Ben Mol provides consultancy to ObsEva, Guerbet and Merck.

CONTRIBUTION TO AUTHORSHIP

JG, MD, DT and BWM equally conceived and designed the review. JG and MD carried out the literature

search, extracted data, performed the data analysis and drafted the article. JG and MD were responsible

for the integrity of the paper. BMW, CW and DT provided subsequent writing and editing. JG, MD, BWM,

CW and DT were responsible for the revision.

DETAILS OF ETHICS APPROVAL

There was no need for ethics approval since this is a systematic review.

FUNDING

There were no financial supports for this review.

13
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16
Figure Caption

17
Figr-1

Figure 1: Flow diagram of study selection

MEDLINE EMBASE CINAHL COCHRANE

(n=276) (n=505) (n=93) (n=270)
Cochrane reviews (n=43)
Other reviews (n=7)
Trials (n=218)
Economic evaluations (n=2)

Records identified through database searching

(n=1144)

Records after duplicates removed Studies excluded by title

(n=585) (n=146)

Records screened Studies excluded by abstract

(n=439) (n=303)

Full-text article assessed

(n=136)

Not eligible studies

(n=52)

Full text not traceable (n=22)

Consecutive/concurrent use of other

pharmacologic methods (n=8)

Not published (n=6)

IUFD as an indication for induction of

labour (n=5)
Eligible studies included in the
review Does not report on adverse events
(n=4)
(n=84)
No original data (n=3)
RCT (n=53) - Data from earlier published articles
Quasi-RCT (n=8) was used (n=2)
Prospective cohort study (n=4) - Comment on another study (n=1)
Retrospective cohort study (n=17)
Case control study (n=2) Data not distinguishable (n=3)
18
Uncertain if every participant in study
group received balloon catheter (n=1)
Table 1. Study characteristics
Study design Total Single Double Previous CS* PROM***
balloon balloon (% of total N) (% of total N)
catheter catheter
RCTs 53 articles 48 articles 7 articles 12 articles 4 articles
(N=5997) (N=5349) (N=648) (N=256)** (N=136)
Quasi RCTs 8 articles 5 articles 3 articles 2 articles -
(N=529) (N=253) (N=276) (N=35)**
Observational studies
Prospective 4 articles 4 articles - 2 articles 1 article
cohort (N=704) (N=704) (N=212) (N=7)
Retrospective 17 articles 15 articles 2 articles 7 articles 5 articles
cohort (N=5773) (N=5675) (N=98) (N=986) (N=282)****
Case-control 2 articles 2 articles - - -
study (N=788) (N=788)
Total 84 articles 74 articles 12 articles 23 articles 10 articles
(N=13791) (N=12769) (N=1022) (N=1489)** (N=425)****
(11%) (3%)

RCT=Randomised controlled trial; Quasi RCT=Quasi Randomised controlled trial; CS=caesarean section; PROM=Premature
rupture of membranes
* Consists of studies with a total cohort of women with previous CS as well as studies with a partial population of women with
previous CS. In the latter, only the amount of women with previous CS was used.
**Ifnan et al. (23) , Greybush et al. (24) , Lokkegaard et al. (25): not included in this count because the percentage of total
population with a previous CS was unclear.
*** Consists of studies with a total cohort of women with PROM as well as studies with a partial population of women with PROM.
In the latter, only the amount of women with PROM was used.
**** Ravasia et al. (26): not included in this count because the percentage of total population with PROM was unclear.

19
Table 2. Pooled estimates of intrapartum infection
Trial references Overall Occurrence with Occurrence
occurrence (n/N) SBC (n/N) with DBC (n/N)
Intrapartum maternal infection
General* (14); (27); (28); (29); (30); 356/2184 356/2184 0
(31)
Suspected** (4); (32); (33); (34); (35) 30/966 30/966 0
Chorioamnionitis*** (20); (36); (37); (38); (39); 60/1807 60/1807 0
(40); (41); (42); (13); (43);
(44); (45); (46); (47); (23)
Fever ≥ 38˚C***,****,† (4); (12); (20); (32); (34); 381/4272 356/3888 25/384
(35); (36); (48); (49); (50);
(51); (52); (53); (54); (55);
(56); (57); (58); (59); (60);
(61); (62); (63); (64); (65);
(66); (67); (68); (69); (70)
Antibiotics (12); (48) 85/1138 59/1031 26/107
Total 50 articles (N=8079) 912/8079 861/7695 51/384
(11.3%) (11.2%) (13.3%)

Total PROM*,**,***,****,† 7 articles (N=411)

Total without 43 articles (N=6,343)
PROM
SBC= Single balloon catheter, DBC= Double balloon catheter, PROM = Premature rupture of membranes
* Collins et al. (27): Partial (n=221) part of total cohort (n=1047) with PROM
Jozwiak et al. (14): Partial (n=17) part of total cohort (n=208) with PROM
Wolff et al. (31): Partial (n=7) part of cohort (n=18) with PROM
** Kruit et al. (33): Total cohort (n=89) with PROM
*** Prager et al. (50): Partial (n=28) part of total cohort (n=198) with PROM
**** Jonsson et al. (56): Partial (n=9) part of cohort (n=42) with PROM
† Matsumoto et al. (57): Partial (n=40) part of cohort (n=134) with PROM

20
Table 3. Pooled estimates of postpartum infection
Trial references Overall Occurrence Occurrence
occurrence (n/N) with SBC (n/N) with DBC (n/N)

Maternal
Postpartum maternal infection
General* (4); (14); (34); (48) 11/943 9/836 2/107
Suspected (12) 42/921 42/921 0
Puerperal fever ≥ 38 (23); (28); (29); (35); (46); 22/1636 21/1594 1/42
(51); (55); (58); (61); (62);
˚C (63); (71)
Endomyometritis**, *** (28); (29); (33); (35); (36); 43/2354 42/2247 1/107
(38); (41); (45); (47); (48);
(56); (72); (73); (74)
Urinary tract infection (12); (29); (60) 6/1387 5/1363 1/24
Wound infection*** (28); (29); (35); (38); (48); 26/1766 24/1635 2/131
(56); (60); (72)
Postpartum antibiotics (44) 1/54 1/54 0
Total 29 articles (N=4538) 151/4538 144/4397 7/141
(3.3%) (3.3%) (5.0%)

Total PROM*,**,*** 3 articles (N=115)

Neonatal
Neonatal infection/sepsis
General** (13); (28); (29); (33); (35); 23/2138 20/2072 3/66
(51); (58); (60); (72);(75);
Suspected* (4); (12); (14); (28); (29); 132/3061 130/2880 2/181
(32); (34); (35); (76); (77)
Proven* (12); (14); (75); (77) 24/1849 24/1744 0/105
Clinical sepsis (28); (29); (35) 23/1177 23/1177 0
Neonatal fever ≥ (36); (61) 1/181 1/181 0
38˚C
Total 20 articles (N=4460) 203/4460 198/4213 5/247
(4.6%) (4.7%) (2.0%)
Total PROM*,** 2 articles (N=106)
SBC= Single balloon catheter, DBC= Double balloon catheter, PROM = Premature rupture of membranes
* Jozwiak et al. (14): Partial (n=17) part of total cohort (n=208) with PROM
** Kruit et al. (33): Total cohort (n=89) with PROM
*** Jonsson et al. (56): Partial (n=9) part of total cohort (n=42) with PROM

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Table 4. Pooled estimates of abnormal uterine activity
Trial references Overall Occurrence Occurrence
occurrence (n/N) with SBC (n/N) with DBC (n/N)
Tachysystole (21);(24); (30); (38); (41); 45/2278 45/1973 0/305
(42); (43); (44); (47);
(48); (51); (55); (61);
(64); (65); (71); (72);
(73); (77); (78); (79);
(80); (81); (82); (83);
(84); (85); (86); (87);
(88);
Hyperstimulation (4); (12); (32); (33); (34); 83/3749 82/3426 2/323
(37); (39); (41); (43);
(45); (47); (48); (50);
(54); (58); (59); (60);
(61); (62); (64); (65);
(68); (73); (76); (82);
(84); (85); (87); (89)
Hypertonus (12); (21); (43); (46); 5/2246 5/2141 0/105
(47); (55); (65); (69);
(71); (72); (77); (78);
(79); (82); (84); (86);
(88); (90)
Uterine hyper- (21); (55); (72); (83); 11/585 11/585 0/0
(86); (90)
stimulation syndrome
Excessive uterine (21); (47); (70); (81); (90) 4/526 1/459 3/67
activity
Total 51 articles (N=5439) 148/5439 143/4918 5/521
(2.7%) (2.9%) (0.96%)
SBC= Single balloon catheter, DBC= Double balloon catheter

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Table 5. Pooled estimated of intra- and postpartum haemorrhage
Trial references Overall Occurrence Occurrence
occurrence (n/N) with SBC (n/N) with DBC (n/N)
Intrapartum haemorrhage
Antepartum bleeding (23); (28); (29); (36); (40); 9/1051 9/1027 0/24
(60); (69); (91)
Bleeding after (4) ;(12); (46); (58); (68); 27/1549 26/1507 1/42
(88)
insertion
Total 14 articles (N=2600) 36/2600 35/2558 1/42
(1.4%) (1.4%) (2.4%)
Postpartum haemorrhage
Unspecified volume (13); (23); (39); (42); (49); 114/1743 104/1597 10/146
(51); (54); (58); (61); (67);
(69); (71); (72); (73); (81);
(92)
> 500 mL (12); (36); (37); (48); (60); 471/1923 420/1716 51/207
(76); (89)
> 1000 mL (4); (12); (14); (28); (29); 408/3291 395/3079 13/212
(32); (33); (34); (35); (48);
(77);
Total 33 articles (N=5819) 993/5819 919/5468 74/351
(17.1%) (16.8%) (21.1%)
SBC= Single balloon catheter, DBC= Double balloon catheter

23
Table 6. Pooled estimates of major maternal complications
Trial references Overall Occurrence Occurrence
occurrence (n/N) with SBC (n/N) with DBC (n/N)
Uterine rupture (4); (13); (12); (14); (21); 11/4255 11/4231 0/24
(23); (24); (26); (32); (34);
(36); (50); (60); (61); (64);
(65); (69); (71); (72); (75);
(82); (83); (84); (85); (92);
(95); (98)
Scar dehiscence (13); (36); (59); (69); (71); 15/557** 14/483** 1/74
(98)
Total 28 articles (N=4329) 26/4329 25/4231 1/98
(0.60%) (0.59%) (1.0%)

Total previous CS 13 articles 26/1373

(N=1373)*,** (1.9%)
Placental abruption (13); (29); (38); (40); (48); 4/3235 4/2961 0/274
(60); (65); (72); (76); (81);
(92); (93)
Suspected, reason for (51) 2/173 2/173 0/0
CS
Total 13 articles (3408) 6/3408 (0.18%) 6/3134 (0.19%) 0/274
Cord prolapse (13); (23); (28); (36); (49); 9/1762 (0.51%) 9/1738 (0.52%) 0/24
(52); (60); (79); (94)
Malpresentation (40); (49); (59); (60); (93) 5/2644 (0.19%) 3/2546 (0.12%) 2/98 (2.0%)
Maternal death (38); (75) 0/800 0/800 0/0
SBC= Single balloon catheter, DBC= Double balloon catheter, CS= Caesarean section
* Sciscione et al. (21): N=3 of total cohort (n=58) had a previous CS, with 0 uterine ruptures. N=3 was used.
Ifnan et al. (23): previous CS in Foley group is unclear. Excluded, because uterine rupture was 0.
Greybush et al. (24): previous CS in Foley group unknown. Excluded, because uterine rupture was 0.
Voon et al. (59): n=58 of total cohort (n=74) had a previous CS. N=58 was used.
** Bujold et al. (98): Scar dehiscence (n=3) was only measured in partial (n=113) part of total cohort (n=255). N=113 was used.

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Table 7. Pooled estimates of minor maternal complications
Trial references Overall Occurrence Occurrence
occurrence (n/N) with SBC (n/N) with DBC (n/N)
Balloon rupture (29); (42) 1/269 (0.37%) 1/269 (0.37%) 0/0
Displacement of (37); (48); (52); (77); (90); 19/1368 (1.4%) 19/1156(1.6%) 0/212
(91)
balloon
Nausea, vomiting (45); (64); (65); (66); (68); 4/398 (1.0%) 4/398 (1.0%) 0/0
(72); (86)
Pain, discomfort * (23); (29); (39); (45); (46); 24 articles report 18 articles 8 articles report
(47); (48); (54); (56); (58);
(60); (64); (65); (66); (67);
on occurrence of report on on occurrence
(74); (76); (77); (78); (80); pain occurrence of of pain
(88); (91); (99); (100) pain
Problems voiding (29); (48); (69) 5/432 (1.2%) 2/325 (0.62%) 3/107 (2.8%)
Genital/vaginal lacerations
Birth canal and/or (69); (76); (81); (92) 6/334 2/191 4/143
cervical injury
Genital and/or (51); (54); (83) 3/273 3/273 0/0
perineal injury
Total 7 articles (N=607) 9/607 (1.5%) 5/464 (1.1%) 4/143 (2.8%)
Allergic reaction (4); (12) 2/1332 (0.15%) 2/1332 (0.15%) 0/0
Unintended (43); (63); (62); (90); (91) 2/467 (0.43%) 2/467 (0.43%) 0/0
amniotomy at
insertion
SBC= Single balloon catheter, DBC= Double balloon catheter
* No quantity analysis was done on this adverse event.

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Table 8. Pooled estimates of fetal complications
Trial references Overall Occurrence Occurrence
occurrence (n/N) with SBC (n/N) with DBC (n/N)
Non-reassuring fetal heart rate
General (12); (45); (43); (60); (70); 111/1936 99/1740 12/196
(72); (77); (81); (82);
(83); (90); (92)
During ripening (36); (58); (77); (80); (90) 11/589 7/442 4/147
As indication for CS (13); (21); (36); (38); (42); 434/4193 395/3973 39/220
(44); (48); (49); (51); (52);
or assisted deliveries
(67); (68); (76); (87); (93);
(94)
Fetal CTG (44); (50); (54); (88); (95) 145/567 145/567 0/0
abnormalities
Fetal tachycardia (12); (33); (43); (64) 85/1106 85/1106 0/0
Fetal bradycardia (43) 0/50 0/50 0/0
Late decelerations (30); (37); (43) 15/591 15/591 0/0
Total 38 articles (N=7336) 793/7336 738/6852 55/484
(10.8%) (10.8%) (11.4%)
Fetal distress
Unspecified (40); (56); (60); (66) 17/195 17/171 0/24
As indication for (4); (12); (14); (32); (34); 98/2207 98/2207 0/0
(37);
assisted vaginal
delivery
As indication for CS (4); (14); (24); (28); (29); 392/4908 377/4725 15/183
(32); (33); (34); (35);
(37); (40); (46); (23); (12);
(50); (58); (59); (61); (62);
(63); (64); (65); (71); (72);
(73); (74); (79); (81); (82);
(89); (96); (97)
Total 35 articles (N=5008) 507/5008 492/4801 15/207
(10.1%) (10.3%) (7.3%)
Meconium stained (12); (21); (23); (28); (30); 460/3295 425/3127 35/168
(38); (41); (40); (50); (51);
liquor (55); (58); (60); (64); (70);
(14.0%) (13.6%) (20.8%)
(72); (73); (76); (79); (80);
(82); (85); (87); (88); (92)
Intrauterine fetal (29); (87); (92); (93) 0/2608 0/2608 0/0
death
SBC= Single balloon catheter, DBC= Double balloon catheter, CS= Caesarean section, CTG = Cardiotocography

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Table 9. Pooled estimates of neonatal complications
Trial references Overall Occurrence with Occurrence
occurrence (n/N) SBC (n/N) with DBC (n/N)
Low Apgar score
1 min *,*** (4); (14); (28); (29); (33); 302/4297 299/4114 3/183
(34); (35); (20); (39);
(7.0%) (7.3%) (1.6%)
(41); (48); (12); (57);
(62); (63); (64); (65);
(72); (73); (74); (76);
(82); (84); (86); (87)
5 min *,**,*** (4); (12); (13); (14); (20); 200/10044 194/9359 (2.1%) 6/685
(25); (28); (29); (30);
(2.0%) (0.88%)
(31); (32); (33); (34);
(35); (36); (37); (38);
(39); (40); (41); (44);
(48); (49); (51); (52);
(55); (56); (58); (60);
(61); (62); (64); (65);
(71); (72); (73); (75);
(76); (77); (81); (82);
(84); (86); (87); (88);
(90); (92); (93); (95)
Low cord pH **** (4); (12); (13); (28); (29); 159/4938 154/4742 (3.3%) 5/196
(32); (33); (34); (35);
(3.2%) (2.6%)
(36); (38); (44); (49);
(51); (52); (54); (60);
(77); (81); (87); (90); (95)
Meconium aspiration (4); (12); (32); (34); (58); 21/1862 (1.1%) 15/1744(0.86%) 6/118 (5.1%)
(64); (76); (79); (85); (87)
syndrome
Asphyxia (4); (12); (14); (32); (34); 20/1940 (1.0%) 16/1773(0.90%) 4/167 (2.4%)
(60); (76); (81); (82)
Encephalopathy (13); (44) 1/208 (0.48%) 1/208 (0.48%) 0/0

NICU admission (4); (12); (13); (14); (24); 650/9065 576/8487 74/578
(25); (28); (29); (30);
(7.2%) (6.8%) (12.8%)
(32); (33); (34); (35);
(37); (38); (41); (43);
(44); (47); (49); (50);
(51); (55); (56); (57);
(58); (60); (65); (73);
(75); (76); (77); (81);
(85); (86); (87); (88);
(90); (93)
Neonatal ward (4); (12); (14); (28); (29); 718/3960 696/3811 22/149
(32); (34); (35); (37);
admission (18.1%) (18.3%) (14.8%)
(48); (54); (58); (64);
(69); (72); (82)
Neonatal/perinatal (12); (13); (14); (38); 6/2058 6/1967 0/91
(51); (55); (60); (81); (90)
death (0.29%) (0.31%)
SBC= Single balloon catheter, DBC= Double balloon catheter, NICU= Neonatal intensive care unit
* Matsumoto et al. (57): No differentiation between Low Apgar-score at 1 min or 5 min. Cases (n=10) are covered by 1 min
Apgar- score in this table.
** Kruit et al. (28): Reports on missing values (n=4) for Apgar score 5 min
*** Kruit et al. (33) Reports on missing values for Apgar score 1 min and 5 min. Missing values in Foley group are not
distinguishable.
**** 9 articles report on missing values for blood cord pH (4);(28);(32);(33);(34);(35);(36);(38);(51)

27