A Randomised Controlled Trial Comparing Induction of Labour with the Propess Vaginal System to the Prostin Vaginal Tablet in Premature Rupture of Membranes at Term

Abstract

Aim: To compare the perinatal outcome and delivery intervals after the induction of labour with the Prostin vaginal tablet versus the Propess vaginal system in pregnant women with term-PROM. Design: One centre paralleled randomised controlled trial with a computer-generated table to allocate treatments. Setting: University Medical Centre in Slovenia. Participants: A total of 205 singleton healthy pregnant women with term-PROM. Intervention: Induction of labour with the Propess vaginal system (intervention group) versus Prostin tablets (control group). Main outcomes: The rate of failed inductions, complications in labour, time intervals between the PROM, induction, the beginning of the active phase, and delivery. Results: A total of 104 patients received Prostin, and 101 patients received Propess. Induction failure rates in the Prostin and the Propess groups were 8/104 (7.7%) and 5/101 (5.0%), respectively (p = 0.80). Delivery abnormalities were uncommon and comparable across the groups. The rates of caesarean sections in the Prostin and Propess groups were 4/96 (4.2%) and 6/96 (6.3%), respectively. The delivery intervals were comparable across the groups. Conclusions: In term-PROM pregnancies, the Propess vaginal system is a safe and effective option for inducing labour.