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

NCT07237880 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-01-06

No results posted yet for this study

Summary

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.

Conditions

  • Labor, Induced

Interventions

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.

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.

Sponsors & Collaborators

  • Hillel Yaffe Medical Center

    lead OTHER_GOV

Principal Investigators

  • Esther Maor-Sagie, MD · Hillel Yaffe Medical Center

  • Rinat Gabbay-Benziv, Prof · Hillel Yaffe Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2027-04-22
Completion
2027-04-22

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07237880 on ClinicalTrials.gov