IV papaverine to speed delivery after term premature rupture of membranes
Official title: I.V Papavrine for Labor Induction in Term PROM: A Prospective Randomized Controlled Trial
Run by Western Galilee Hospital-Nahariya · NCT07517796 · Data updated 2026-11-12
This trial will test whether a single intravenous dose of papaverine given around 12 hours after membranes break helps women at term with an unfavorable cervix deliver sooner and improves outcomes for mother and baby.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 110 (estimated) |
| Sponsor | Western Galilee Hospital-Nahariya Government |
| Locations | 1 site (Nahariya, Israel) |
| Status | Recruiting |
| Started | October 22, 2025 |
| Main results expected | October 22, 2027 |
| Study ends | October 22, 2027 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT07517796 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with singleton term pregnancies (37–42 weeks), PROM within 12 hours before enrollment, Bishop score <8, cephalic presentation, a viable fetus with reassuring heart rate, and no contraindication to vaginal delivery.
✕Probably not a fit
Women with multiple gestation, prior cesarean, major fetal anomalies, meconium-stained fluid, suspected chorioamnionitis, or other contraindications to vaginal delivery are excluded and would not be expected to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, placebo-controlled Phase 4 trial at Galilee Medical Center comparing IV papaverine to placebo in women with term premature rupture of membranes (PROM) and a Bishop score below 8. Eligible women with singleton, cephalic, viable fetuses who present within 12 hours of membrane rupture will be enrolled and randomized to receive papaverine or placebo, with the dose given around 12 hours after PROM. The primary outcome is the interval from membrane rupture to delivery, and secondary outcomes include maternal and neonatal infectious morbidity and other labor outcomes. The trial tests whether an antispasmodic that relaxes cervical smooth muscle can shorten latency and improve delivery course without increasing harms.
Why it matters
Potential benefit: If successful, this could shorten the time from membrane rupture to delivery and potentially reduce maternal and neonatal infection risk and need for additional interventions.
How similar studies have gone: Antispasmodic agents have previously been reported to speed cervical dilation and shorten the first stage of labor in some settings, but IV papaverine specifically for term PROM has not been systematically tested and is relatively novel in this indication.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Singleton pregnancy * Term gestation (37-42 weeks) * Term PROM prior to active labor * Duration of PROM \<12 hours at enrollment * Bishop score \<8 * Cephalic presentation * Viable fetus with reassuring fetal heart rate Exclusion Criteria: * • Multiple gestation * Previous cesarean delivery * Major fetal anomalies * Contraindication to vaginal delivery * Meconium-stained amniotic fluid * Suspected chorioamnionitis
Where it's running
-
Galilee Medical Center
Nahariya, Israel, Israel Recruiting
Study contacts
- Study coordinator: Maya Frank Wolf, professor
- Email: mayaw@gmc.gov.il
- Phone: • 972:50-7887800
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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.