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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-22

Study Completion Date

2027-04-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain

NCT05759364

Induction of Labor Pain, Acute Labor Pain +1 more

UNKNOWN NA

IV PAPAVERINE Prior to Propess for Labor Induction

NCT06550232

Induced Vaginal Delivery

COMPLETED PHASE4

Papaverine and Oxytocin vs Oxytocin Alone in Labor Induction

NCT06547437

Induced; Birth Labor Onset and Length Abnormalities

NOT_YET_RECRUITING NA

Drotaverine to Shorten the Length of Labor

NCT01639027

Prolonged First Stage of Labor Failure of Cervical Dilation as Antepartum Condition Labor Pain +1 more

COMPLETED PHASE2/PHASE3

The Impact of Papaverine on First Stage of Labor

NCT02362139

Duration of Labor.

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor, Induced

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm Name: Papaverine

"Participants receive 80 mg intravenous papaverine immediately after removal of the double-balloon catheter, together with initiation of oxytocin augmentation."

Group Type EXPERIMENTAL

Papaverine 80 mg IV

Intervention Type 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 Type: Placebo Comparator

"Participants receive intravenous normal saline immediately after removal of the double-balloon catheter, together with initiation of oxytocin augmentation."

Group Type PLACEBO_COMPARATOR

Placebo (Normal Saline)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes