Foley catheter versus vaginal misoprostol: Randomized controlled trial (PROBAAT-M Study) and systematic review and meta-analysis of literature

Marta Jozwiak*, Mieke Ten Eikelder, Katrien Oude Rengerink, Christianne De Groot, Hanneke Feitsma, Marc Spaanderman, Mariëlle Van Pampus, Jan Willem De Leeuw, Ben Willem Mol, Kitty Bloemenkamp

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

42 Citations (Scopus)


Objectives To assess effectiveness and safety of Foley catheter versus vaginal misoprostol for term induction of labor. Study Design This trial randomly allocated women with singleton term pregnancy to 30-mL Foley catheter or 25-μg vaginal misoprostol tablets. Primary outcome was cesarean delivery rate. Secondary outcomes were maternal and neonatal morbidity and time to birth. Additionally, a systematic review was conducted. Results Fifty-six women were allocated to Foley catheter, 64 to vaginal misoprostol tablets. Cesarean delivery rates did not differ significantly (25% Foley versus 17% misoprostol; relative risk [RR] 1.46, 95% confidence interval [CI] 0.72 to 2.94), with more cesarean deliveries due to failure to progress in the Foley group (14% versus 3%; RR 4.57, 95% CI 1.01 to 20.64). Maternal and neonatal outcomes were comparable. Time from induction to birth was longer in the Foley catheter group (36 hours versus 25 hours; p < 0.001). Meta-analysis showed no difference in cesarean delivery rate and reduced vaginal instrumental deliveries and hyperstimulation in the Foley catheter group. Other outcomes were not different. Conclusion Our trial and meta-analysis showed no difference in cesarean delivery rates and less hyperstimulation with fetal heart rate changes and vaginal instrumental deliveries when using Foley catheter, thereby supporting potential advantages of the Foley catheter over misoprostol as ripening agent.

Original languageEnglish
Pages (from-to)145-155
Number of pages11
JournalAmerican journal of perinatology
Issue number2
Publication statusPublished - 1 Feb 2014


  • cervical ripening
  • cesarean delivery rate
  • Foley catheter
  • labor induction
  • misoprostol
  • prostaglandin E1


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