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

Jones MN 1 , Palmer KR 2 , Pathirana MM 3 , Cecatti JG 4 , Filho OBM 5 , Marions L 6 Show all authors , Edlund M 6 , Prager M 6 , Pennell C 7 , Dickinson JE 8 , Sass N 9 , Jozwiak M 10 , Eikelder MT 11 , Rengerink KO 12 , Bloemenkamp KWM 13 , Henry A 14 , Løkkegaard ECL 15 , Christensen IJ 16 , Szychowski JM 17 , Edwards RK 18 , Beckmann M 19 , Diguisto C 20 , Gouge AL 20 , Perrotin F 20 , Symonds I 21 , O'Leary S 22 , Rolnik DL 23 , Mol BW 24 , Li W 25

Affiliations 

  • 1 Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, VIC, Australia. Electronic address: madeleine.jones@monash.edu
  • 2 Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, VIC, Australia. Electronic address: kirsten.palmer@monash.edu
  • 3 Adelaide Medical School and Robinson Research Institute, The University of Adelaide, Adelaide, SA, Australia
  • 4 State University of Campinas, São Paulo, Brazil
  • 5 Faculdade de Ciencias Médicas, University of Pernambuco, Pernambuco, Brazil
  • 6 Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden
  • 7 School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia
  • 8 School of Women's and Infants' Health, University of Western Australia, Perth, WA, Australia
  • 9 Departamento de Obstetricia, Universidade Federal de São Paulo, São Paulo, Brazil
  • 10 Gynaecologic Oncology, Erasmus University Medical Centre, Rotterdam, Netherlands
  • 11 Department of Gynaecology, Leiden University Medical Centre, Leiden, Netherlands
  • 12 Department of Biostatistics and Research Support, Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht, Netherlands
  • 13 Department of Obstetrics, WKZ Birth Centre, Division Woman and Baby, UMC Utrecht, Utrecht, Netherlands
  • 14 Medicine & Health, University of New South Wales, Kensington, NSW, Australia. Electronic address: amanda.henry@unsw.edu.au
  • 15 Department of Gynaecology and Obstetrics, Nordsjællands Hospital, Hillerød, Denmark. Electronic address: Ellen.Christine.Leth.Loekkegaard@regionh.dk
  • 16 University of Copenhagen, Copenhagen Biocentre, Copenhagen, Denmark
  • 17 School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA
  • 18 College of Medicine, University of Oklahoma, Oklahoma City, OK, USA
  • 19 Mothers, Babies and Women's Health Services, Mater Health, South Brisbane, QLD, Australia
  • 20 Department of Obstetrics, Gynaecology and Fetal Medicine, Centre Hospitalier Régional Universitaire de Tours, Tours, France
  • 21 School of Medicine, International Medical University, Kuala Lumpur, Malaysia
  • 22 Robinson Research Institute, University of Adelaide, Adelaide, SA, Australia
  • 23 Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, VIC, Australia. Electronic address: daniel.rolnik@monash.edu
  • 24 Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, VIC, Australia; Aberdeen Centre for Women's Health Research, School of Medicine, University of Aberdeen, Aberdeen, UK. Electronic address: ben.mol@monash.edu
  • 25 Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, VIC, Australia. Electronic address: wentao.li@monash.edu
Lancet, 2022 Nov 12;400(10364):1681-1692.
PMID: 36366885 DOI: 10.1016/S0140-6736(22)01845-1

Abstract

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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