NCT07826533 Intravenous Papaverine for Term Prelabor Rupture of Membranes
| NCT ID | NCT07826533 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wolfson Medical Center |
| Condition | Premature Rupture of Fetal Membranes |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2027-04-21 |
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.
This trial targets 200 participants in total. It began in 2025-03-20 with a primary completion date of 2027-04-21.
⚠ 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 randomized, double-blind, placebo-controlled trial evaluates whether intravenous papaverine, administered as an adjunct to oxytocin, shortens the time to delivery in women with term premature rupture of membranes (PROM). Participants are randomized in a 1:1 ratio to receive either intravenous papaverine 80 mg in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo, administered one hour after initiation of oxytocin. The primary outcome is the interval from study infusion to delivery. Secondary outcomes include mode of delivery and maternal and neonatal outcomes.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Gestational age ≥37 weeks with term PROM * No active contractions * Cervical dilation \<2 cm * Vertex presentation * PROM duration between 2 and 12 hours Exclusion Criteria: * Previous cesarean delivery * Contraindication to vaginal delivery * Known fetal malformation * Known allergy to papaverine * Cardiac arrhythmia * Glaucoma * Hepatitis or other hepatic disease * Atrioventricular (AV) block * Congestive heart disease * Recent ischemic heart disease * Increased intracranial pressure * Active labor, defined as cervical dilation ≥6 cm * Contraindication to uterine relaxation, including significant uterine bleeding or fetal distress Active infection or chorioamnionitis Use of medications with potentially hazardous interactions with papaverine
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07826533 clinical trial?
This trial is open to female participants only, studying Premature Rupture of Fetal Membranes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07826533 currently recruiting?
Yes, NCT07826533 is actively recruiting participants. Contact the research team at elielbob@gmaill.com for enrollment information.
Where is the NCT07826533 trial being conducted?
This trial is being conducted at Holon, Israel.
Who is sponsoring the NCT07826533 clinical trial?
NCT07826533 is sponsored by Wolfson Medical Center. The trial plans to enroll 200 participants.