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

Objective To assess the safety and effectiveness of a transcervical Foley catheter compared to vaginal prostaglandin E2 inserts for term induction of labour. Study design We conducted an open-label randomized controlled trial in five hospitals in the Netherlands. Women with a singleton term pregnancy in cephalic presentation, intact membranes, unfavourable cervix, and no prior caesarean section were enrolled. Participants were randomly allocated by a web-based randomization system to induction of labour with a 30 ml Foley catheter or 10 mg slow-release vaginal prostaglandin E2 inserts in a 1:1 ratio. Due to the nature of the intervention this study was not blinded. The primary outcome was the caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. Additionally, we carried out a systematic review and meta-analysis of similar studies. Results We analyzed 226 women: 107 received a Foley catheter and 119 inserts. Caesarean section rates were comparable (20% versus 22%, RR 0.90, 95% CI 0.54-1.50). Secondary outcomes showed no differences. We observed no serious maternal or neonatal morbidity. Meta-analysis showed comparable caesarean section rates, but significantly fewer cases of hyperstimulation during the ripening phase when a Foley catheter was used. Conclusions We found, in this relatively small study, no differences in effectiveness and safety of induction of labour with a Foley catheter and 10 mg slow release vaginal prostaglandin E2 inserts. Meta-analysis confirmed a comparable caesarean section rate, and showed fewer cases of hyperstimulation when a Foley catheter was used.