PGE2 then oxytocin versus oxytocin for starting labor after your water breaks at term.
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | National Hospital of Obstetrics and Gynecology Academic / other |
| Locations | 1 site (Hanoi, Hanoi) |
| Trial ID | NCT07366359 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous randomized trials have suggested possible benefits of dinoprostone before oxytocin but were small and inconsistent, so higher-quality evidence is still needed.
Eligibility criteria
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 this trial is running
Hanoi, Hanoi
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.