Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07517796

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

Prelabor rupture of membranes (PROM) at term complicates approximately 8% of pregnancies and is associated with increasing maternal and neonatal infectious morbidity as the latency period to delivery lengthens. Consequently, most clinical guidelines recommend active management with labor induction within 24 hours following membrane rupture. Cervical status at the time of induction plays a critical role in labor outcomes, and women with an unfavorable cervix, commonly defined as a Bishop score below 8, are at increased risk of prolonged labor and induction failure. The uterine cervix is composed primarily of connective tissue, with smooth muscle accounting for approximately 15% of its structure and concentrated mainly beneath the internal cervical os. Papaverine is a musculotropic antispasmodic agent that acts directly on smooth muscle, leading to reduced muscle spasm and enhanced relaxation. The pharmacokinetic profile of papaverine includes a rapid onset of action within approximately 10 minutes and a short half-life of 0.5-2 hours, making it a potentially suitable adjunct during early labor. Antispasmodic agents have been shown to accelerate cervical dilatation and shorten the first stage of labor; however, their role in the management of term PROM has not been systematically evaluated. We therefore aim to investigate whether intravenous administration of papaverine in women with term PROM shortens the interval from membrane rupture to delivery and improves cervical ripening and maternal and neonatal outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Treatment and study plan

Papaverine arm

Drug

given 12 houres after rupture of membranes

Placebo

Other

I.V seline

Primary outcomes

  1. Time interval from rupture of membranes to delivery

    Time frame: up to 5 days from rupture of membranes

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

Secondary outcomes

  1. change in bishop score following intervention

    Time frame: baseline to 6-12 hours after intervention

    Bishop score messured at admission and 18 houres after rupture of membranes, and comparing the delta bishop scores between the groups

  2. mode of delivary

    Time frame: At delivery/birth

    Mode of delivery categorized as vaginal (spontaneous or operative) or cesarean delivery

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Frank Wolf, professor

CONTACT

[email protected]

• 972:50-7887800

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.