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Intravenous Papaverine for Term Prelabor Rupture of Membranes

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07826533
Lead Sponsor Wolfson Medical Center
Conditions
(from sponsor)		 Premature Rupture of Fetal Membranes
Related terms Premature Rupture of Fetal Membranes
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov