I.V Papavrine for Labor Induction in Term PROM

NCT07517796 | Recruiting Phase 4 DMC

• 1 other identifier: 0152-25-NHR
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Premature Rupture of Membranes

Keywords

premature rupture of membranes; papaverine; bishop score

Outcome Measures

Primary Outcomes (1)

• Time interval from rupture of membranes to delivery

  Time from rupture of membrane to delivery, measured in hours, including pre and post intervention periods

  up to 5 days from rupture of membranes

Secondary Outcomes (2)

• change in bishop score following intervention

  baseline to 6-12 hours after intervention

• mode of delivary

  At delivery/birth

Study Arms (2)

papaverine arm

ACTIVE COMPARATOR

IV-papaverine 80 mg in 100 ml 0.9% saline, once, 12 hours after rupture of membranes

Drug: Papaverine arm

Control arm

PLACEBO COMPARATOR

I.V 100 ml 0.9% saline, 12 hours after rupture of membranes

Other: Placebo

Interventions

Papaverine arm DRUG

given 12 houres after rupture of membranes

papaverine arm

Placebo OTHER

I.V seline

Control arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galilee Medical Center

Nahariya, Israel, Israel

RECRUITING

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Maya Frank Wolf, professor

CONTACT

• 972:50-7887800; mayaw@gmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group allocation will be double blind. The randomization table will be available only to one member of the study, who will prepare the medications according to the allocated intervention. Participants will receive intravenous 0.9% normal saline with or without papaverine. The same bottles of normal saline will be use for the papaverine and placebo groups. Accordingly, the participants will be masked for the intervention. The participants, the researchers including the obstetricians who assess the bishop score, the caregiver nurse who administrated the medication, the data collector, and the statistician will be blinded to the group allocations throughout the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Fetal Maternal Unit

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: April 8, 2026
• Study Start: October 22, 2025
• Primary Completion (Estimated): October 22, 2027
• Study Completion (Estimated): October 22, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

IL (1)