RecruitingPhase 4NCT07517796

I.V Papavrine for Labor Induction in Term PROM

I.V Papavrine for Labor Induction in Term PROM: A Prospective Randomized Controlled Trial


Sponsor

Western Galilee Hospital-Nahariya

Enrollment

110 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria7

  • 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 Criteria6

  • Multiple gestation
  • Previous cesarean delivery
  • Major fetal anomalies
  • Contraindication to vaginal delivery
  • Meconium-stained amniotic fluid
  • Suspected chorioamnionitis

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Interventions

DRUGPapaverine arm

given 12 houres after rupture of membranes

OTHERPlacebo

I.V seline


Locations(1)

Galilee Medical Center

Nahariya, Israel, Israel

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NCT07517796