IV PAPAVERINE Prior to Propess for Labor Induction

June 22, 2025 updated by: Dr. Maya Wolf, Western Galilee Hospital-Nahariya

The Effect of IV PAPAVERINE 80 mg Prior to Propess on Bishop Score and Pain, Double Blinded Randomized Placebo Controlled Trial

The investigators aim to evaluate the effect of administering papaverine prior to PGE2 insertion on changes in Bishop-scores and on the induction-to-delivery interval.

Researchers will compare drug papaverine to a placebo

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

More than 22% of all pregnant women undergo induction of labor. Induction of labor is usually medically indicated for maternal and fetal related conditions; however, elective induction has become more common since the ARRIVE trial. Women with an unfavourable cervix, according to Bishop-score (<6), are prone to higher induction failure rates and are candidates for cervical ripening.

The cervix is composed of connective tissue and smooth-muscle located mainly beneath the internal os. Papaverine is an antispasmodic-musculotropic drug that targets smooth-muscle, resulting in decreased muscle spasm and subsequent smooth-muscle relaxation. The half-life of the drug is in the range of 0.5-2 hours, and its action starts 10 minutes after administration. Short-term use of papaverine during the first trimester has been reported as safe. However, outcome data are lacking of the use of mucosotropic-agents prior to PGE2 (propess) insertion. We will investigate this in a trial in which the co-primary outcomes were the change in Bishop-score after PGE2 extraction and the PGE2 insertion-to-delivery interval

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Israel
      • Nahariyya, Israel
        • Galilee Medical Center

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:

  • singleton term pregnancy
  • bishop score
  • need for labor induction with PGE2
  • vertex presentation
  • viable fetus

Exclusion Criteria:

  • Prelabour rupture of membrane
  • Twins pregnancy
  • previous cesarean section
  • allergy to the study medication
  • fetal anomaly contraindications for vaginal delivery
  • maternal supraventricular tachicardia

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: papaverine arm
IV-papaverine 80 mg in 100 ml 0.9% saline, once
Drug: Papaverine
Within 30-minutes prior to catheter insertion, women in the intervention group will receive IV-papaverine 80 mg in 100 ml 0.9% saline
Placebo Comparator: Control arm
I.V 100 ml 0.9% saline
Other: placebo
I.V Sallne

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delta Bishop score
Time Frame: 24 hours
The bishop score before and after propess insertion
24 hours
the time from propess insertion until delivery
Time Frame: 72 hours
induction to delivery time
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal satisfaction scores
Time Frame: 24 hours
maternal satisfaction on 1-5 scale. higher scores mean higher satisfaction
24 hours
visual analogue scale score
Time Frame: 24 hours
pain assessment using a 10-point visual analogue scale
24 hours

Collaborators and Investigators

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

Sponsor

Western Galilee Hospital-Nahariya

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)

August 12, 2024

Primary Completion (Actual)

March 23, 2025

Study Completion (Actual)

March 23, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 22, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0112-24-NHR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The authors are willing to share the data of the study upon request of the Editors.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

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.

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