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.
Study 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
Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Time From Study Infusion to Delivery — From administration of the study infusion until delivery, assessed up to 48 hours Time, measured in hours, from administration of the assigned study infusion (papaverine or placebo) to delivery.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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