PGE2 then oxytocin versus oxytocin for starting labor after your water breaks at term.
Official title: Comparison of the Effectiveness of Labor Induction Using Dinoprostone Followed by Oxytocin Versus Oxytocin Alone in Term Pregnancies With Premature Rupture of Membranes and an Unfavorable Cervix - A Randomized Clinical Trial
Run by National Hospital of Obstetrics and Gynecology · NCT07366359 · Data updated 2026-11-12
This test will see whether giving a 6-hour vaginal dinoprostone (PGE2) insert before oxytocin or starting oxytocin right away works better for women 18 and older with a single baby whose water breaks at 37–42 weeks and whose cervix isn't ready.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 450 (estimated) |
| Sponsor | National Hospital of Obstetrics and Gynecology Academic / other |
| Locations | 1 site (Hanoi, Hanoi) |
| Status | Recruiting |
| Started | February 10, 2026 |
| Main results expected | December 2027 |
| Study ends | January 2028 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT07366359 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with a single baby in head-down position at 37–42 weeks whose water has broken (term PROM), who have no contractions and a Bishop score ≤6, and who have no contraindications to vaginal delivery or prostaglandins.
✕Probably not a fit
Women in active labor, with prior uterine surgery (e.g., cesarean), chorioamnionitis, non-reassuring fetal status, major fetal anomalies, or contraindications to prostaglandin or vaginal delivery are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares two common induction approaches for women with term prelabor rupture of membranes (term PROM) and an unfavorable cervix. One group receives a 6-hour vaginal dinoprostone (Propess) insert to ripen the cervix and then intravenous oxytocin if labor has not begun; the other group receives immediate intravenous oxytocin. Eligible participants are pregnant people aged ≥18 with a singleton cephalic fetus at 37–42 weeks and a Bishop score ≤6, and care is provided at the National Hospital of Obstetrics and Gynecology in Hanoi. The study will track delivery mode and maternal and neonatal safety outcomes including infection and need for cesarean delivery.
Why it matters
Potential benefit: If successful, this approach could increase the chance of vaginal delivery and reduce infections and cesarean deliveries in women with term PROM and an unfavorable cervix.
How similar studies have gone: Previous randomized trials have suggested possible benefits of dinoprostone before oxytocin but were small and inconsistent, so higher-quality evidence is still needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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National Hospital of Obstetrics and Gynecology
Hanoi, Hanoi, Vietnam Recruiting
Study contacts
- Study coordinator: Khuyen T.H Truong, MD
- Email: khuyenth.hmu@gmail.com
- Phone: +84983851754
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.