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

Recruiting now · Not applicable

Conditions studied: Premature Rupture of Fetal Membranes, Labor, Induced, Cervical Ripening

In brief

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.

Key facts

Study ID

NCT07366359

Run by

National Hospital of Obstetrics and Gynecology

People needed

450

Starts

2026-02-10

Expected to finish

2028-01-01

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Maternal age ≥ 18 years
• Gestational age from 37 to 42 weeks, determined by last menstrual period or by a first- or second-trimester ultrasound
• Live singleton fetus
• Prelabor rupture of membranes (PROM) confirmed by at least one of the following:
• Amniotic fluid visibly draining from the cervical os during sterile speculum examination
• Pool of fluid in the posterior fornix
• Cephalic presentation
• Bishop score ≤ 6
• No spontaneous uterine contractions
• No contraindications for vaginal delivery

You may not qualify if…

• Active labor
• Previous uterine surgery (e.g., cesarean section)
• Chorioamnionitis or non-reassuring fetal status
• Major fetal anomalies
• Contraindications to prostaglandin or vaginal delivery
• Refusal to participate

Where it is running

• National Hospital of Obstetrics and Gynecology — Hanoi, Hanoi, Vietnam (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.