NCT07517796 I.V Papavrine for Labor Induction in Term PROM
| NCT ID | NCT07517796 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Western Galilee Hospital-Nahariya |
| Condition | Premature Rupture of Membranes |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-10-22 |
| Primary Completion | 2027-10-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 110 participants in total. It began in 2025-10-22 with a primary completion date of 2027-10-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective randomized controlled trial aims to evaluate whether intravenous administration of papaverine 12 hours after term PROM reduces the interval from membrane rupture to delivery and improves maternal and neonatal outcomes. Researchers will compare drug papaverine to a placebo
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07517796 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Premature Rupture of Membranes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07517796 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07517796 currently recruiting?
Yes, NCT07517796 is actively recruiting participants. Contact the research team at mayaw@gmc.gov.il for enrollment information.
Where is the NCT07517796 trial being conducted?
This trial is being conducted at Nahariya, Israel.
Who is sponsoring the NCT07517796 clinical trial?
NCT07517796 is sponsored by Western Galilee Hospital-Nahariya. The trial plans to enroll 110 participants.