Comparing Labor Induction Methods Using Dinoprostone Followed by Oxytocin Versus Oxytocin Alone for Women With Term Premature Rupture of Membranes and an Unfavorable Cervix

What this Trial Is About

Researchers are investigating the best way to induce labor for pregnant women whose water breaks at term before labor begins, a condition called term prelabor rupture of membranes term PROM. This study focuses on women with term PROM and an unfavorable cervix, comparing two common induction methods to find which one may be safer and more effective for both mother and baby. The trial aims to provide clearer guidance on labor induction when the cervix is not yet ready and is being conducted as a randomized clinical trial at a hospital in Vietnam. The study compares two induction strategies one group receives a vaginal dinoprostone insert Propess for 6 hours to soften the cervix, followed by intravenous oxytocin if labor does not start the other group receives immediate intravenous oxytocin without prior cervical ripening. Both treatments are part of routine care and include continuous fetal monitoring and standard management of any complications during labor. Participants are randomly assigned to one of these two groups and remain in their assigned group throughout the trial. Participants will be monitored from induction until delivery, with detailed assessments including mode of delivery, time from induction to birth, maternal and neonatal complications, and womens experiences of labor. Safety measures such as fetal heart rate monitoring and handling of uterine contractions are part of the protocol. The primary outcome is the rate of vaginal delivery, with secondary outcomes including maternal infections, neonatal health measures, and patient satisfaction. The study duration includes monitoring up to 28 days after delivery for some outcomes.

PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)