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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07517796