[Foley catheter versus prostaglandin E2 gel for induction of labour at term: the PROBAAT study]

Abstract

Item does not contain fulltextObjective To study the effectiveness and safety of induction of labour with a Foley catheter compared with vaginal prostaglandin E2 gel in full term pregnant women. Design Multicentre, randomised, open-label trial in 12 hospitals in the Netherlands between February 2009 and May 2010. Methods Women scheduled for induction of labour at full term singleton pregnancy in cephalic presentation, intact membranes, and an unripe cervix (Bishop score < 6) were enrolled by means of an on-line system. Participants were randomly allocated to induction of labour with a transcervical Foley catheter or vaginal prostaglandin E2 gel. The primary outcome was caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from induction to birth. Results A total of 824 women were allocated to induction of labour with a Foley catheter (n = 412) or prostaglandin E2 (n = 412). Caesarean section rates were comparable (23% versus 20%, RR 1.13, 95% CI 0.87 to 1.47). In the Foley catheter group fewer instrumental deliveries for foetal distress were performed (12% versus 18%, RR 0.68, 95% CI 0.49 to 0.95). Time to delivery (median hours (IQR)) was longer (29 (15-35) versus 18 (12-33)). Fewer mothers had suspected intrapartum infection (2% versus 4%, RR 0.41, 95% CI 0.17-0.98). Significantly fewer neonates were admitted toaneonatal ward after induction with a Foley catheter (12% versus 20%, RR 0.60, 95% CI 0.43 to 0.83). Conclusion In women with an unripe cervix at term, induction of labour with a Foley catheter does not reduce caesarean section rates, but there are fewer side-effects