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

Hillel Yaffe Medical Center

Status: Enrolling

Conditions: Labor, Induced

Treatments: Drug: Papaverine 80 mg IV; Drug: Placebo (Normal Saline)

Study type: Interventional

Funder types: Other

Identifiers

NCT07237880

0100-24-HYMC

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 2 patient groups, including a placebo group

Arm Name: Papaverine

Experimental group

Description:

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

Treatment:

Drug: Papaverine 80 mg IV

Arm Type: Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (Normal Saline)