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RECRUITING Not applicable ClinicalTrials.gov

Intravenous Papaverine for Term Prelabor Rupture of Membranes

Sponsor: Wolfson Medical Center • ClinicalTrials.gov ID: NCT07826533

Registry updated: 2026-09-17
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Description

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.

Interventions

  • Papaverine (Drug)
    Papaverine 80 mg diluted in 100 mL of 0.9% normal saline, administered intravenously as a single study infusion.
  • Normal Saline Placebo Infusion (Drug)
    100 mL of 0.9% normal saline, administered intravenously as a single placebo study infusion.

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

Conditions

Premature Rupture of Fetal Membranes

Locations

  • The Edith Wolfson Medical Center — Holon, Israel
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record