PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM) (NCT07366359) | Clinical Trial Compass
RecruitingNot Applicable
PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)
Vietnam450 participantsStarted 2026-02-10
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vaginal delivery
Timeframe: From induction until delivery, assessed up to 36 hours after randomization
Trial details
NCT IDNCT07366359
SponsorNational Hospital of Obstetrics and Gynecology