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

This study is being done to learn more about the best way to start labor for pregnant women whose water breaks at term before labor begins, a condition called term prelabor rupture of membranes (term PROM). When this happens and the cervix is not ready for labor, it is unclear which induction method works best and is safest for mother and baby. The purpose of this study is to compare two common ways to induce labor in women with term PROM and an unfavorable cervix (Bishop score ≤ 6). One group will receive a vaginal dinoprostone insert (Propess) for 6 hours to soften the cervix, followed by oxytocin if labor does not start. The other group will receive immediate oxytocin through a vein. Pregnant women aged 18 years or older with a single baby in head-down position at 37-42 weeks, whose water has broken and whose cervix is not yet favorable, may be able to join this study. All care will be provided at the National Hospital of Obstetrics and Gynecology in Hanoi, Vietnam, where both medicines are already used in routine practice. The main outcome is how many women have a vaginal birth. The study will also look at how long it takes from induction to birth, complications for mothers and babies, and women's experiences of labor. The results may help doctors choose the safest and most effective way to induce labor for women with term PROM in the future.

NCT Number	NCT07366359
Lead Sponsor	National Hospital of Obstetrics and Gynecology
Conditions	Premature Rupture of Fetal Membranes, Labor, Induced, Cervical Ripening
Enrollment	450 participants
Start Date	2026-02-10
Primary Completion	2027-12 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-20