Intravenous Papaverine for Term Prelabor Rupture of Membranes

September 14, 2026 updated by: Wolfson Medical Center

The Effect of Papaverine on Labour in Term Premature Rupture of Membranes (PROM)

This randomized, double-blind, placebo-controlled trial evaluates whether intravenous papaverine, administered as an adjunct to oxytocin, shortens the time to delivery in women with term premature rupture of membranes (PROM). Participants are randomized in a 1:1 ratio to receive either intravenous papaverine 80 mg in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo, administered one hour after initiation of oxytocin. The primary outcome is the interval from study infusion to delivery. Secondary outcomes include mode of delivery and maternal and neonatal outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Women hospitalized in the labor and delivery unit with term premature rupture of membranes at 37 weeks of gestation or later are screened for participation. Eligible participants have no active contractions, cervical dilation of less than 2 cm, vertex presentation, and a duration of membrane rupture between 2 and 12 hours.

Following informed consent, participants are randomized in a 1:1 ratio to receive intravenous papaverine 80 mg diluted in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo. The study infusion is administered one hour after initiation of oxytocin.

Treatment allocation is blinded. One study-team member prepares the study solution according to the randomization table, while the remainder of the study team remains blinded to treatment allocation. The primary outcome is the interval from study infusion to delivery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Holon, Israel, 5822012
        • Recruiting
        • The Edith Wolfson Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Gestational age ≥37 weeks with term PROM
  • No active contractions
  • Cervical dilation <2 cm
  • Vertex presentation
  • PROM duration between 2 and 12 hours

Exclusion Criteria:

  • Previous cesarean delivery
  • Contraindication to vaginal delivery
  • Known fetal malformation
  • Known allergy to papaverine
  • Cardiac arrhythmia
  • Glaucoma
  • Hepatitis or other hepatic disease
  • Atrioventricular (AV) block
  • Congestive heart disease
  • Recent ischemic heart disease
  • Increased intracranial pressure
  • Active labor, defined as cervical dilation ≥6 cm
  • Contraindication to uterine relaxation, including significant uterine bleeding or fetal distress Active infection or chorioamnionitis Use of medications with potentially hazardous interactions with papaverine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Papaverine
Participants received intravenous papaverine 80 mg diluted in 100 mL of 0.9% normal saline.
Drug: Papaverine
Papaverine 80 mg diluted in 100 mL of 0.9% normal saline, administered intravenously as a single study infusion.
Placebo Comparator: Placebo
Participants received 100 mL of intravenous 0.9% normal saline as placebo.
Drug: Normal Saline Placebo Infusion
100 mL of 0.9% normal saline, administered intravenously as a single placebo study infusion.
Other Names:
  • 0.9% Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time From Study Infusion to Delivery
Time Frame: From administration of the study infusion until delivery, assessed up to 48 hours
Time, measured in hours, from administration of the assigned study infusion (papaverine or placebo) to delivery.
From administration of the study infusion until delivery, assessed up to 48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mode of Delivery
Time Frame: From rupture of membranes until delivery, assessed up to 48 hours
Mode of delivery, categorized as vaginal or cesarean delivery
From rupture of membranes until delivery, assessed up to 48 hours
Maternal Infectious Complications
Time Frame: From rupture of membranes until delivery, assessed up to 48 hours
Proportion of participants with maternal infectious complications
From rupture of membranes until delivery, assessed up to 48 hours
Postpartum Hemorrhage
Time Frame: From rupture of membranes until delivery, assessed up to 48 hours
Proportion of participants with postpartum hemorrhage
From rupture of membranes until delivery, assessed up to 48 hours
Apgar Score at 5 Minutes
Time Frame: 5 minutes after birth
Apgar score recorded 5 minutes after birth, ranging from 0 to 10
5 minutes after birth
Umbilical Cord pH Below 7.1
Time Frame: At birth, based on umbilical artery cord blood sampling
Proportion of neonates with umbilical cord blood pH below 7.1
At birth, based on umbilical artery cord blood sampling
Neonatal Infection
Time Frame: From birth through neonatal hospital discharge, assessed up to 7 days after birth
Proportion of neonates diagnosed with neonatal infection
From birth through neonatal hospital discharge, assessed up to 7 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wolfson Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 21, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 21, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WOMC-0047-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings