Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-balloon Catheter

January 4, 2026 updated by: Hillel Yaffe Medical Center

This prospective, randomized, double-blind controlled trial aims to evaluate whether intravenous papaverine, administered immediately after the removal of a double-balloon catheter used for cervical ripening, can shorten the duration of labor in term pregnant women undergoing induction of labor. Papaverine is an antispasmodic medication that relaxes smooth muscle and is commonly used in obstetrics, although its effect on labor progression following mechanical cervical ripening has not been fully studied.

Eligible participants include nulliparous and multiparous women with a singleton pregnancy at 37-42 weeks, admitted for induction of labor with a double-balloon catheter. After catheter removal, participants will be randomized in a 1:1 ratio to receive either 80 mg intravenous papaverine or placebo (normal saline), administered by the midwife who is not involved in clinical decision-making. Clinical staff and participants will remain blinded to group allocation.

The primary outcomes are the time from drug administration to complete cervical dilation and the duration of the second stage of labor. Secondary outcomes include mode of delivery, maternal complications (such as perineal tears and postpartum hemorrhage), oxytocin augmentation duration and maximum dose, and neonatal outcomes.

This study seeks to determine whether papaverine can safely and effectively reduce labor duration following mechanical cervical ripening.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

184

Phase

  • 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 Backup

Study Locations

  • Israel
      • Hadera, Israel
        • Recruiting
        • Hillel Yaffe Medical Center
        • 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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant individuals aged 18-50 years
  • Singleton pregnancy
  • Gestational age 37-42 weeks
  • Admission for induction of labor with a double-balloon catheter
  • Planned vaginal delivery
  • Ability to provide informed consent

Exclusion Criteria:

  • Previous cesarean delivery
  • Multiple gestation
  • Contraindication to vaginal delivery
  • Known hypersensitivity to papaverine
  • Known major fetal anomaly
  • Any condition requiring immediate delivery or precluding safe participation (as determined by the treating physician)

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
Intervention / Treatment
Experimental: Arm Name: Papaverine
"Participants receive 80 mg intravenous papaverine immediately after removal of the double-balloon catheter, together with initiation of oxytocin augmentation."
Drug: Papaverine 80 mg IV
Single intravenous dose of 80 mg papaverine administered immediately after removal of the double-balloon cervical ripening catheter. The medication is given by the midwife as part of the randomized, double-blind protocol, followed by initiation of oxytocin augmentation according to standard labor management.
Placebo Comparator: Arm Type: Placebo Comparator
"Participants receive intravenous normal saline immediately after removal of the double-balloon catheter, together with initiation of oxytocin augmentation."
Drug: Placebo (Normal Saline)
Single intravenous dose of normal saline administered immediately after removal of the double-balloon cervical ripening catheter. The placebo is administered in an identical manner to the papaverine intervention as part of the randomized, double-blind protocol, followed by initiation of oxytocin augmentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from study drug administration to complete cervical dilation
Time Frame: From study drug administration to complete cervical dilation, up to 24 hours.
Time in hours from intravenous administration of papaverine or placebo after removal of the double-balloon catheter until complete cervical dilation (10 cm), as documented in the partogram/electronic medical record.
From study drug administration to complete cervical dilation, up to 24 hours.

Collaborators and Investigators

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

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Esther Maor-Sagie, MD, Hillel Yaffe Medical Center
  • Study Director: Rinat Gabbay-Benziv, Prof, Hillel Yaffe Medical Center

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)

April 22, 2025

Primary Completion (Estimated)

April 22, 2027

Study Completion (Estimated)

April 22, 2027

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

November 15, 2025

First Posted (Estimated)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0100-24-HYMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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