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Intravenous Papaverine for Term Prelabor Rupture of Membranes

RecruitingNAAges any - anyFemaleWolfson Medical Center
NCT07826533 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Papaverine
  • Normal Saline Placebo Infusion
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Where

1 site
The Edith Wolfson Medical Center
Holon, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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