Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative): an individual participant data meta-analysis of randomised controlled trials

doi:10.1016/S0140-6736(22)01845-1

The Lancet

Volume 400, Issue 10364, 12 November 2022, Pages 1681-1692

, , , , , , , , , , , , , , , , , , , …

https://doi.org/10.1016/S0140-6736(22)01845-1 Get rights and content

Summary

Background

Induction of labour is one of the most common obstetric interventions globally. Balloon catheters and vaginal prostaglandins are widely used to ripen the cervix in labour induction. We aimed to compare the effectiveness and safety profiles of these two induction methods.

Methods

We did an individual participant data meta-analysis comparing balloon catheters and vaginal prostaglandins for cervical ripening before labour induction. We systematically identified published and unpublished randomised controlled trials that completed data collection between March 19, 2019, and May 1, 2021, by searching the Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and PubMed. Further trials done before March 19, 2019, were identified through a recent Cochrane review. Data relating to the combined use of the two methods were not included, only data from women with a viable, singleton pregnancy were analysed, and no exclusion was made based on parity or membrane status. We contacted authors of individuals trials and participant-level data were harmonised and recoded according to predefined definitions of variables. Risk of bias was assessed with the ROB2 tool. The primary outcomes were caesarean delivery, indication for caesarean delivery, a composite adverse perinatal outcome, and a composite adverse maternal outcome. We followed the intention-to-treat principle for the main analysis. The primary meta-analysis used two-stage random-effects models and the sensitivity analysis used one-stage mixed models. All models were adjusted for maternal age and parity. This meta-analysis is registered with PROSPERO (CRD42020179924).

Findings

Individual participant data were available from 12 studies with a total of 5460 participants. Balloon catheters, compared with vaginal prostaglandins, did not lead to a significantly different rate of caesarean delivery (12 trials, 5414 women; crude incidence 27·0%; adjusted OR [aOR] 1·09, 95% CI 0·95–1·24; I²=0%), caesarean delivery for failure to progress (11 trials, 4601 women; aOR 1·20, 95% CI 0·91–1·58; I²=39%), or caesarean delivery for fetal distress (10 trials, 4441 women; aOR 0·86, 95% CI 0·71–1·04; I²=0%). The composite adverse perinatal outcome was lower in women who were allocated to balloon catheters than in those allocated to vaginal prostaglandins (ten trials, 4452 neonates, crude incidence 13·6%; aOR 0·80, 95% CI 0·70–0·92; I²=0%). There was no significant difference in the composite adverse maternal outcome (ten trials, 4326 women, crude incidence 22·7%; aOR 1·02, 95% CI 0·89–1·18; I²=0%).

Interpretation

In induction of labour, balloon catheters and vaginal prostaglandins have comparable caesarean delivery rates and maternal safety profiles, but balloon catheters lead to fewer adverse perinatal events.

Funding

Australian National Health and Medical Research Council and Monash Health Emerging Researcher Fellowship.

Introduction

Induction of labour is one of the most common obstetric procedures, occurring in as many as one in four births in high-income countries, and one in ten births globally.¹ Induction is performed when the risks of continued pregnancy outweigh the benefits. Rates of labour induction have substantially increased since 2010, from 25% to 35% in Australia,² and from 20% to 32% in the UK.³ This increase reflects the increased acceptability of the labour induction process to both women and health professionals.

In women with an unripe cervix, labour induction starts with cervical ripening and then uterine contractions can be initiated. Cervical ripening can be achieved with mechanical methods, commonly a single-balloon catheter or double-balloon catheter, or pharmacological methods, including exogenous prostaglandins such as misoprostol (PGE1) or dinoprostone (PGE2). One-fifth of labour inductions in women with an unripe cervix do not result in a vaginal birth, and these women go on to require a caesarean section.⁴ Induction of labour also carries the risks of rare adverse events, including maternal and neonatal morbidity and mortality. Hence, identifying the optimal method of labour induction is of enormous importance for women and babies worldwide.

Research in context

Evidence before this study

Induction of labour is one of the most common obstetric interventions that is applied to tens of millions of women each year globally. Balloon catheters and vaginal prostaglandins are widely used to ripen the cervix in labour induction. We searched PubMed on May 01, 2021, to identify systematic reviews and meta-analyses that compared balloon catheters and vaginal prostaglandins for labour induction, using the search terms “balloon”, “Foley”, “catheter”, “prostaglandin”, “dinoprostone”, “misoprostol”, “induction”, and “ripening”. Previous reviews have shown that balloon catheters are probably as effective as vaginal prostaglandins for vaginal birth, but the comparison between the two methods in terms of maternal and perinatal safety remains unclear because assessments of individual adverse outcomes using summary data of trials are underpowered.

Added value of this study

This is the first individual participant data meta-analysis that compared balloon catheters and vaginal prostaglandins for both effectiveness and safety. The robustness of the included trials, the collaborative process between the coordinating team and trial investigators, and the predefined analysis enabled the findings to be interpreted with confidence. The diverse settings of the included trials ensured good generalisability of the findings. We not only assessed the overall caesarean delivery but also specifically considered the two major indications for caesarean delivery: failure to progress and fetal compromise. Empowered by the participant-level data to construct composite outcomes for adverse events, new evidence regarding maternal and perinatal safety was obtained from analyses with sufficient power.

Implications of all the available evidence

Balloon catheters and vaginal prostaglandins are comparable regarding effectiveness, as measured by mode of birth and maternal safety profile. New evidence generated in this study indicates an improved neonatal safety profile with balloon catheters. Increasing the use of balloon catheters rather than vaginal prostaglandins in labour induction could potentially prevent a considerable number of adverse perinatal events given the large volume of labour inductions worldwide. Shared decision making with women that jointly considers effectiveness, safety, and practicalities is important for choosing the right method.

Since the 2000s, advances have made it easier to identify which women would benefit from labour induction, through indications for maternal⁵ or fetal concern,⁶ and when in pregnancy labour should be induced. Studies have suggested that labour could even be induced at 39 weeks of gestation in uncomplicated pregnancies to reduce the caesarean delivery rate.7, 8 However, the use of a suboptimal method for induction could counteract the advances of these benefits for women and neonates, especially those related to a worse safety profile. Even if the difference in adverse events between induction methods is small on an individual basis, the global effect could be large given that induction of labour is applied to around 14 million women each year.

Several aggregate meta-analyses, including the latest Cochrane review, suggest that balloon catheters are equally effective as vaginal PGE2 for cervical ripening in achieving vaginal birth, although no firm conclusion can be drawn for the neonatal safety profile between the two methods.9, 10, 11, 12, 13, 14, 15, 16, 17 Conventional meta-analyses using aggregate data will not answer this question given the low incidence of individual safety outcomes and the use of slightly different endpoints between studies. An individual patient data meta-analysis allows for the evaluation of interventions on the level of row-by-row data. The benefits of this approach include greater flexibility and scope of analyses, standardisation of definitions, improved statistical power, and improved quality and trustworthiness of data.¹⁸ Importantly, an individual participant data meta-analysis allows composite outcomes to be assessed, potentially addressing the problem of underpowered analysis of individual safety measures in previous meta-analyses of labour induction, especially perinatal safety outcomes.

Here, we report an individual participant data meta-analysis that compares the effectivness and safety of use of balloon catheters and vaginal prostaglandins for labour induction. We hypothesised that induction of labour with balloon catheters would result in similar caesarean delivery rates to vaginal prostaglandins, with better perinatal and maternal outcomes.

Section snippets

Overview

This international collaborative individual participant data meta-analysis followed a prospectively registered protocol (PROSPERO [CRD42020179924]) and a statistical analysis plan produced in advance. Ethics approval was obtained from the Monash Health Human Research Ethics Committee on May 15, 2020 (RES-20–0000328Q-64577). Findings are reported following the PRISMA-IPD statement.¹⁹

Search strategy and selection criteria

We searched the Cochrane Library of registered trials, ClinicalTrials.gov, WHO International Clinical Trials

Results

We identified 471 unique references through our search (figure 1). After screening titles and abstracts, 60 completed trials were potentially eligible for inclusion and enquiries were sent, of which four were further excluded for using high-dose PGE1 and 43 that did not provide individual participant data. Out of 43 trials that did not share data, we could extract summary data for primary and secondary outcomes from 32 trials (4313 women). Characteristics of trials excluded after enquiry or not

Discussion

This individual participant data meta-analysis of 12 randomised controlled trials reporting on 5460 women undergoing induction of labour showed that balloon catheter and vaginal prostaglandins led to similar caesarean delivery rates. The adverse composite maternal outcome was also comparable with both methods, but induction with a balloon catheter improved composite perinatal outcomes.

Strengths of this study include the continued, collaborative process between the coordinating team and the

Data sharing

The protocol, statistical analysis plan, and codebook are available on request. The trial investigators who shared individual participant data for the purposes of the meta-analysis retain ownership of their trial data and any requests for access to individual participant data should be made directly to them (they can be accessed via email and the email addresses can be found in their original publications which are cited in this manuscript).

Declaration of interests

BWM has received grants from the Australian National Health and Medical Research Council (NHMRC), personal fees from ObsEva, personal fees from Merck, personal fees from Guerbet, and grants from Merck, outside the submitted work. BWM was also an investigator for one of the trials included in the individual participant data meta-analysis. DLR has received fees to participate in advisory boards from Alexion and travel support and lecture fees from the International Society of Ultrasound in

References (41)

CM Koopmans et al.
Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT): a multicentre, open-label randomised controlled trial
Lancet
(2009)
M Jozwiak et al.
Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial
Lancet
(2011)
M Jozwiak et al.
Foley catheter or prostaglandin E2 inserts for induction of labour at term: an open-label randomized controlled trial (PROBAAT-P trial) and systematic review of literature
Eur J Obstet Gynecol Reprod Biol
(2013)
PR Chavakula et al.
Misoprostol versus Foley catheter insertion for induction of labor in pregnancies affected by fetal growth restriction
Int J Gynaecol Obstet
(2015)
L Orr et al.
Combination of Foley and prostaglandins versus Foley and oxytocin for cervical ripening: a network meta-analysis
Am J Obstet Gynecol
(2020)
WHO recommendations for induction of labour
Australia's mothers and babies
Rise in proportion of induced labours, new maternity figures show
Induction of labour
(2008)
KE Boers et al.
Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)
BMJ
(2010)

WA Grobman et al.

Labor induction versus expectant management in low-risk nulliparous women

N Engl J Med

(2018)

M Alkmark et al.

Induction of labour at 41 weeks or expectant management until 42 weeks: a systematic review and an individual participant data meta-analysis of randomised trials

PLoS Med

(2020)

W Chen et al.

A systematic review and network meta-analysis comparing the use of Foley catheters, misoprostol, and dinoprostone for cervical ripening in the induction of labour

BJOG

(2016)

Y Li et al.

Foley catheter balloon versus prostaglandins for cervical ripening and labor induction: a systematic review and meta-analysis

Int J Clin Exp Med

(2016)

YM Du et al.

Double-balloon catheter versus prostaglandin E2 for cervical ripening and labour induction: a systematic review and meta-analysis of randomised controlled trials

BJOG

(2017)

Y-R Liu et al.

Double-balloon catheter versus dinoprostone insert for labour induction: a meta-analysis

Arch Gynecol Obstet

(2019)

L Zhu et al.

Intracervical Foley catheter balloon versus dinoprostone insert for induction cervical ripening: a systematic review and meta-analysis of randomized controlled trials

Medicine (Baltimore)

(2018)

HM Hamido et al.

Intravaginal misoprostol versus Foley catheter balloon for induction of labor: a systematic literature review, meta-analysis, meta-regression, and trial sequential analysis

Int J Clin Obstet Gynaecol

(2020)

H Wang et al.

Controlled-release dinoprostone insert versus Foley catheter for labor induction: a meta-analysis

J Matern Fetal Neonatal Med

(2016)

ML Ten Eikelder et al.

Induction of labor using a Foley catheter or misoprostol: a systematic review and meta-analysis

Obstet Gynecol Surv

(2016)

Cited by (11)

Routine vaginal examination to assess labor progress at 8 compared to 4 hours after early amniotomy following Foley balloon ripening in the labor induction of multiparas: a randomized trial
2024, American Journal of Obstetrics and Gynecology MFM
Vaginal examination to monitor labor progress is recommended at least every 4 hours, but it can cause pain and embarrassment to women. Trial data are limited on the best intensity for vaginal examination. Vaginal examination is not needed for oxytocin dose titration after an amniotomy has been performed and oxytocin infusion started. The Foley balloon commonly ripens the cervix without strong contractions. Amniotomy and oxytocin infusion are usually required to drive labor.
This study aimed to evaluate the first vaginal examination at 8 vs 4 hours after amniotomy-oxytocin after Foley ripening in multiparous labor induction.
A randomized controlled trial was conducted from October 2021 to September 2022 at the University Malaya Medical Center, Kuala Lumpur, Malaysia. Multiparas at term were recruited at admission for labor induction. Participants were randomized to a first routine vaginal examination at 8 or 4 hours after Foley balloon ripening and amniotomy. Titrated oxytocin infusion was routinely commenced after amniotomy to initiate contractions. The 2 primary outcomes were the time from amniotomy to delivery (noninferiority hypothesis) and maternal satisfaction (superiority hypothesis). Data were analyzed using the Student t test, Mann-Whitney U test, and chi-square test (or Fisher exact test), as suitable for the data.
A total of 204 women were randomized, 102 to each arm. Amniotomy to birth intervals were 4.97±2.47 hours in the 8-hour arm and 5.79±3.17 hours in the 4-hour arm (mean difference, −0.82; 97.5% confidence interval, −1.72 to 0.08; P=.041; Bonferroni correction), which were noninferior within the prespecified 2-hour upper margin, and the maternal satisfaction scores (11-point 0–10 numerical rating scale) with allocated labor care were 9 (interquartile range, 8–9) in the 8-hour arm and 8 (interquartile range, 7–9) in the 4-hour arm (P=.814). In addition, oxytocin infusion to birth interval difference was noninferior within the 97.5% confidence interval (−1.59 to 0.23) margin of 1.3 hours. Of the maternal outcomes, the amniotomy to first vaginal examination intervals were 3.9±1.8 hours in the 8-hour arm and 3.4±1.3 hours in the 4-hour arm (P=.026), and the numbers of vaginal examinations were 2.00 (interquartile range, 2.00–3.00) in the 8-hour arm and 3.00 (interquratile range, 2.00–3.25) in the 4-hour arm (P<.001). For the 8-hour arm, the first vaginal examination was less likely to be as scheduled and more likely to be indicated by sensation to bear down (P<.001), and the epidural analgesia rates were lower (13/102 participants [12.7%] in the 8-hour arm vs 28/102 participants [27.5%] in the 4-hour arm; relative risk, 0.46; 95% confidence interval, 0.26–0.84; P=.009). Other outcomes of the mode of delivery, indications for cesarean delivery, and delivery blood loss were not different. Neonatal outcomes were not different.
Routine first vaginal examination at 8 hours compared with that at 4 hours was noninferior for the time to birth but did not improve maternal satisfaction.
Six compared with 12 hours of Foley balloon placement for labor induction in nulliparous women with unripe cervices: a randomized controlled trial
2023, American Journal of Obstetrics and Gynecology MFM
Compared with a planned 12-hour placement of a double-balloon catheter, a planned 6-hour placement of a double-balloon catheter shortens the labor induction to delivery interval. The Foley catheter is low cost. Moreover, it has at least comparable effectiveness to the proprietary double-balloon labor induction devices. Of note, a 6-hour placement of a Foley balloon catheter in nulliparas has not been evaluated.
This study aimed to evaluate 6- vs 12-hour Foley balloon placement for cervical ripening in the labor induction of nulliparas.
A randomized controlled trial was conducted at the Universiti Malaya Medical Centre from January 2022 to August 2022. Nulliparas aged ≥18 years, with a term, singleton pregnancy in cephalic presentation, with intact membranes, with reassuring fetal heart rate tracing, with an unripe cervix, and without any significant contractions, were recruited at admission for labor induction. Participants were randomized after successful Foley balloon insertion, for the balloon to be left passively in place for 6 or 12 hours and then removed to check for a ripened cervix. Amniotomy was performed once the cervix had ripened, followed by titrated oxytocin infusion to expedite labor and delivery. The primary outcome was the labor induction to delivery interval. The secondary outcomes were mostly from the core outcome set for trials on labor induction of labor trial reporting, such as change in the Bishop score after the intervention, use of an additional method for cervical ripening, time to delivery after double-balloon device removal, mode of delivery, indication for cesarean delivery, duration of oxytocin infusion, blood loss during delivery, presence of a third- or fourth-degree perineal tear, maternal infection, maternal satisfaction regional analgesia in labor, length of hospital stay, intensive care unit admission, cardiorespiratory arrest, need for hysterectomy. The neonatal outcomes were Apgar score at 1 and 5 minutes, neonatal intensive care unit admission, cord pH, neonatal sepsis, fetal birthweight, birth trauma, hypoxic-ischemic encephalopathy, or need for therapeutic hypothermia. Data were analyzed using the t test, Mann-Whitney U test, chi-square test, and Fisher exact test, as appropriate for the data type.
Overall, 240 women were randomized, 120 to each arm. The median labor induction to delivery intervals were 21.3 hours (interquartile range, 16.2–27.9) for the 6-hour balloon catheter placement and 26.0 hours (interquartile range, 21.5–30.9) for the 12-hour balloon catheter placement (P<.001). Of the secondary outcomes, for 6- vs 12-hour balloon catheter placement, the sequential use of additional cervical ripening agent (mostly Foley reinsertion) was 33 of 119 (27.5%) vs 17 of 120 (14.2%) (relative risk, 1.94; 95% confidence interval, 1.15–3.29; P=.011), Bishop score increase was 3 (interquartile range, 2.00–3.75) vs 3 (2.25–4.00) (P=.002), and the rate of recommendation to a friend was 83 of 118 (70.3%) vs 101 of 119 (84.9%) (relative risk, 0.83; 95% confidence interval; 0.72–0.95; P=.007), respectively. Cesarean delivery rates were 52 of 119 (43.7%) for the 6-hour balloon catheter placement and 64 of 120 (53.3%) for the 12-hour balloon catheter placement (relative risk, 0.82; 95% confidence interval, 0.63–0.07; P=.136), and maternal satisfaction scores (0–10 numerical rating scale) were 7 (interquartile range, 6–9) for the 6-hour balloon catheter placement and 7 (interquartile range, 7–9) for the 12-hour balloon catheter placement (P=.880).
Compared with a planned 12-hour Foley balloon catheter placement, a planned 6-hour Foley balloon placement shortens the time to birth, despite less cervical ripening at Foley balloon catheter removal and more additional cervical ripening agent use. However, the 6-hour balloon catheter placement was less likely to be recommended to a friend than the 12-hour balloon catheter placement.
Six vs 12 hours of Foley catheter balloon placement in the labor induction of multiparas with unfavorable cervixes: a randomized controlled trial
2023, American Journal of Obstetrics and Gynecology MFM
Planned 6- vs 12-hour placement of the double-balloon catheter for cervical ripening in labor induction hastens delivery. The Foley catheter is low-priced and typically performs at least as well as the proprietary double-balloon devices in labor induction. Maternal satisfaction with labor induction is usually inversely related to the speed of the process.
This study aimed to compare Foley balloon placement for 6 vs 12 hours in the labor induction of multiparas with unfavorable cervixes.
A randomized controlled trial was conducted in a university hospital in Malaysia from January to October of 2022. Eligible multiparous women admitted for induction of labor for various indications were enrolled. Participant inclusion criteria were multiparity (at least 1 previous vaginal delivery of ≥24 weeks' gestation), age ≥18 years, term pregnancy >37 weeks' gestation, singleton pregnancy, cephalic presentation, intact membranes, normal fetal heart rate tracing, no significant contractions (< 2 in 10 minutes), and unfavorable cervix (Bishop score < 6). Participants were randomized after successful Foley balloon insertion for the balloon to be left in place for 6 or 12 hours of passive ripening before removal to check cervical suitability for amniotomy. The primary outcomes were the induction-to-delivery interval and maternal satisfaction with the allocated intervention assessed using a visual numerical rating scale (0–10). Secondary outcomes were derived in part from the core outcome set for trials on induction of labor (Core Outcomes in Women's and Newborn Health [CROWN]).
Maternal outcomes were change in first Bishop score after intervention, use of additional method for cervical ripening, time to delivery after balloon removal, mode of delivery, indication for cesarean delivery, duration of oxytocin infusion, blood loss during delivery, presence of third- or fourth-degree perineal tear, maternal infection, use of regional analgesia in labor, length of hospital stay, intensive care unit (ICU) admission, cardiorespiratory arrest, and need for hysterectomy. The secondary neonatal outcomes were Apgar score at 1 and 5 minutes, neonatal intensive care unit (NICU) admission, cord blood pH, neonatal sepsis, birthweight, birth trauma, hypoxic-ischemic encephalopathy, or need for therapeutic hypothermia. Analyses were conducted with the t-test, Mann–Whitney U test, chi-square test, and Fisher exact test, as appropriate.
A total of 220 women were randomized (110 to each intervention). Regarding the 2 primary outcomes, the induction-to-delivery intervals were a median (interquartile range) of 15.9 (12.0–24.0) and 21.6 (17.3–26.0) hours (P<.001), and maternal satisfaction scores were 7 (6–8) and 7 (6–8) (P=.734) for 6- and 12-hour placement, respectively. The following rates were observed for 6- and 12-hour placement, respectively: sequential use of additional cervical ripening agent (Foley reinsertion)—29 per 110 (26.4%) and 13 per 110 (11.8%) (relative risk, 2.23; 95% confidence interval, 1.23–4.10; P=.006); spontaneous balloon expulsion—22 per 110 (20.0%) and 37 per 110 (33.6%) (relative risk, 0.60; 95% confidence interval, 0.38–0.94; P=.022); and recommendation of the allocated intervention to a friend—61 per 110 (73.6%) and 87 per 110 (79.1%) (relative risk, 0.90; 95% confidence interval, 0.80–1.08; P=.341). Other secondary outcomes, including cesarean delivery, were not significantly different.
Foley balloon placement for 6 hours for cervical ripening in parous women hastens birth but does not increase maternal satisfaction relative to 12-hour placement. Foley reinsertion for additional ripening was more frequent in the 6-hour group.
Extended balloon labour induction: A single arm proof of concept trial
2023, European Journal of Obstetrics and Gynecology and Reproductive Biology: X
Mechanical labour induction with a transcervical balloon is as effective as pharmacological methods, with fewer adverse effects. Its use has been limited to labour induction with an unfavourable cervix able to retain the balloon. We have developed an innovative approach using 2–3 balloons side-by-side to extend the benefits of mechanical labour induction/augmentation with a favourable cervix without having to resort to amniotomy or uterotonics.
To assess the effectiveness of side-by-side balloons for extended labour induction/augmentation.
We conducted a single arm proof of concept trial at Princess Marina Hospital (PMH) in Gaborone, Botswana. Participants were assessed as unsuitable for single balloon labour induction based on a modified Bishop cervical score of 7 or more. Three Foley catheters taped symmetrically side by side were passed through the cervix and inflated with 60mls each. Traction was applied with a weight of 250mls water suspended over the bed-end. The use of uterotonics, time from induction to birth, mode of birth, Apgar scores and adverse maternal and neonatal outcomes were recorded. Participants’ satisfaction with the method of labour induction was assessed using a descriptive scale.
We enrolled 20 participants of whom two were nulliparous. Indications for labour induction were mainly late term (70%) and hypertensive disorders of pregnancy (25%). The mean cervical score was 7.2. Overall, 17 (85%) of the participants achieved a vaginal birth, of whom 5 required oxytocin for labour augmentation. Four of these had requested removal of the balloons, one due to discomfort and three felt the process was taking too long. Three participants underwent caesarean birth. The mean time from initiation of labour induction to vaginal birth was 16 h (standard deviation (SD) 8.4) and 20 h for caesarean birth (SD 10.5). There were no 5-minute Apgar scores below 7 nor neonatal admissions. One baby required brief resuscitation. There were no adverse maternal outcomes.
This proof-of-concept study suggests that use of side-by-side balloons in participants with favourable cervix is effective in achieving vaginal birth in most participants without uterotonics or amniotomy. There were no adverse outcomes, though the study was too small to exclude the possibility of rare adverse outcomes. This offers a novel option for labour induction/augmentation, particularly where uterotonics or amniotomy are best avoided such as prior caesarean birth, vertical infection transmission risk and in settings with limited capacity for fetal surveillance. The results clearly justify larger randomized trials to evaluate this novel approach with greater precision. On the basis of the current study we are developing a purpose-designed balloon for extended balloon labour induction.
Induction of labour: first, do no harm
2022, The Lancet
Vaginal misoprostol versus vaginal dinoprostone for cervical ripening and induction of labour: An individual participant data meta-analysis of randomised controlled trials
2024, BJOG: An International Journal of Obstetrics and Gynaecology

View all citing articles on Scopus

View full text

ArticlesBalloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative): an individual participant data meta-analysis of randomised controlled trials

Summary

Background

Methods

Findings

Interpretation

Funding

Introduction

Section snippets

Overview

Search strategy and selection criteria

Results

Discussion

Data sharing

Declaration of interests

Lancet

Lancet

Eur J Obstet Gynecol Reprod Biol

Int J Gynaecol Obstet

Am J Obstet Gynecol

WHO recommendations for induction of labour

Australia's mothers and babies

Rise in proportion of induced labours, new maternity figures show

Induction of labour

Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

BMJ

Labor induction versus expectant management in low-risk nulliparous women

N Engl J Med

Induction of labour at 41 weeks or expectant management until 42 weeks: a systematic review and an individual participant data meta-analysis of randomised trials

PLoS Med

A systematic review and network meta-analysis comparing the use of Foley catheters, misoprostol, and dinoprostone for cervical ripening in the induction of labour

BJOG

Foley catheter balloon versus prostaglandins for cervical ripening and labor induction: a systematic review and meta-analysis

Int J Clin Exp Med

Double-balloon catheter versus prostaglandin E2 for cervical ripening and labour induction: a systematic review and meta-analysis of randomised controlled trials

BJOG

Double-balloon catheter versus dinoprostone insert for labour induction: a meta-analysis

Arch Gynecol Obstet

Intracervical Foley catheter balloon versus dinoprostone insert for induction cervical ripening: a systematic review and meta-analysis of randomized controlled trials

Medicine (Baltimore)

Intravaginal misoprostol versus Foley catheter balloon for induction of labor: a systematic literature review, meta-analysis, meta-regression, and trial sequential analysis

Int J Clin Obstet Gynaecol

Controlled-release dinoprostone insert versus Foley catheter for labor induction: a meta-analysis

J Matern Fetal Neonatal Med

Induction of labor using a Foley catheter or misoprostol: a systematic review and meta-analysis

Obstet Gynecol Surv

Articles
Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative): an individual participant data meta-analysis of randomised controlled trials