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I.V Papavrine for Labor Induction in Term PROM

This prospective randomized controlled trial aims to evaluate whether intravenous administration of papaverine 12 hours after term PROM reduces the interval from membrane rupture to delivery and improves maternal and neonatal outcomes. Researchers will compare drug papaverine to a placebo

Condition(s)Premature Rupture of Membranes
StatusRecruiting
PhasePhase 4
Study typeInterventional
SummaryThis prospective randomized controlled trial aims to evaluate whether intravenous administration of papaverine 12 hours after term PROM reduces the interval from membrane rupture to delivery and improves maternal and neonatal outcomes. Researchers will compare drug papaverine to a placebo
Who can participateInclusion Criteria: * • Singleton pregnancy * Term gestation (37-42 weeks) * Term PROM prior to active labor * Duration of PROM \<12 hours at enrollment * Bishop score \<8 * Cephalic presentation * Viable fetus with reassuring fetal heart rate Exclusion Criteria: * • Multiple gestation * Previous cesarean delivery * Major fetal anomalies * Contraindication to vaginal delivery * Meconium-stained amniotic fluid * Suspected chorioamnionitis
Ages18 Years to 45 Years
SexFemale
Accepts healthy volunteersYes
Lead sponsorWestern Galilee Hospital-Nahariya
LocationsNahariya, Israel, Israel
Start date2025-10-22
NCT IDNCT07517796
Official listinghttps://clinicaltrials.gov/study/NCT07517796

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