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Intravenous Papaverine for Term Prelabor Rupture of Membranes
Sponsor: Wolfson Medical Center
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.
Official title: The Effect of Papaverine on Labour in Term Premature Rupture of Membranes (PROM)
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-03-20
Completion Date
2027-04-21
Last Updated
2026-09-17
Healthy Volunteers
No
Conditions
Interventions
Papaverine
Papaverine 80 mg diluted in 100 mL of 0.9% normal saline, administered intravenously as a single study infusion.
Normal Saline Placebo Infusion
100 mL of 0.9% normal saline, administered intravenously as a single placebo study infusion.
Locations (1)
The Edith Wolfson Medical Center
Holon, Israel