Intravenous Papaverine for Term Prelabor Rupture of Membranes
The Effect of Papaverine on Labour in Term Premature Rupture of Membranes (PROM)
Wolfson Medical Center
200 participants
Mar 20, 2025
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
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Interventions
Papaverine 80 mg diluted in 100 mL of 0.9% normal saline, administered intravenously as a single study infusion.
100 mL of 0.9% normal saline, administered intravenously as a single placebo study infusion.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07826533