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

NCT07237880 | Recruiting DMC

• 1 other identifier: 0100-24-HYMC
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time from study drug administration to complete cervical dilation

  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.

Study Arms (2)

Arm Name: Papaverine

EXPERIMENTAL

"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

Arm Type: Placebo Comparator

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)

Interventions

Papaverine 80 mg IV DRUG

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.

Arm Name: Papaverine

Placebo (Normal Saline) DRUG

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.

Arm Type: Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: "Only pregnant individuals who identify as female are eligible to participate. The study population consists exclusively of pregnant women admitted for induction of labor at term."
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, Israel

RECRUITING

MeSH Terms

Interventions

Papaverine; Saline Solution

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Esther Maor-Sagie, MD

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

• Rinat Gabbay-Benziv, Prof

  Hillel Yaffe Medical Center

  STUDY DIRECTOR

Central Study Contacts

Esther Maor-Sagie, MD

CONTACT

9727744248; estimaorsagie@gmail.com

Rinat Gabbay-Benziv, Prof

CONTACT

+972-4-7744514; rinatg@hymc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): April 22, 2027
• Study Completion (Estimated): April 22, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

IL (1)