Comparison of Vaginal Prostaglandin E2 Delivery System Versus Expectant Management in Term Premature Rupture of Membranes: A Randomized Controlled Trial

Abstract

Background: Premature rupture of the membranes (PROM) occurring after the 37th week of gestation, prior to the onset of regular contractions, affects approximately 8% of pregnancies and typically leads to the spontaneous onset of labor. A prolonged interval between PROM and delivery increases the risk of maternal infection and early neonatal sepsis. This prospective, randomized study aimed to assess the efficacy, safety, and maternal satisfaction associated with the use of a vaginal prostaglandin E2 (PGE2) delivery system compared to expectant management approach following PROM. Methods: Term pregnant women with a singleton cephalic presentation, who experienced PROM within 4–12 hours and had an unripe cervix, were randomized into 2 groups. The intervention group received labor induction using a slow-release 10 mg dinoprostone (PGE2) vaginal delivery system, whereas the control group underwent expectant management. If active labor had not commenced within 24 hours of enrollment, labor was induced with oxytocin in both groups. Results: In this prospective randomized study, 74 pregnant women with PROM after the 37th week of gestation, prior to before the onset of active labor, were enrolled. Active labor began within 24 hours after enrollment in 54% of the control group and 77% of the intervention group (p = 0.036). The intervention group had a 3.42-hour shorter interval from randomization to delivery; however, this difference was not statistically significant (p = 0.067). When analyzing time to spontaneous vaginal delivery, administration of PGE2 in the intervention group was associated with a 4.3-hour reduction in delivery time (p = 0.029). There was no statistically significant difference regarding mode of delivery between the groups, with 6% of cesarean section in the intervention group vs. 15% in the control group (p = 0.343). No significant differences were observed between the groups in oxytocin use, labor complication rates, neonatal outcomes, or participant satisfaction. Notably, in a significant proportion of participants (37%) in the intervention group, the vaginal PGE2 delivery system was unintentionally expelled prior to the onset of active labor. Conclusion: The slow-release PGE2 vaginal system reduced the time from randomization to the onset of active labor and to vaginal delivery in pregnant women after PROM, without impacting the mode of delivery maternal and neonatal complications rates, or satisfaction rate compared to expectant management approach. Early induction of labor following PROM with a PGE2 vaginal system represents an effective and safe alternative to expectant labor management. Clinical Trial Registration: This study is registered at https://classic.clinicaltrials.gov/ (registration number: NCT05430711).

Keywords

• premature rupture of membranes
• prom
• induction of labor
• prostaglandin e2 vaginal system
• dinoprostone