Papaverine and Oxytocin vs Oxytocin Alone in Labor Induction

NCT ID: NCT06547437

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-12-31

Brief Summary

This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone

Detailed Description

Labor induction is a common obstetric procedure aimed at stimulating uterine contractions to initiate labor, often due to medical or obstetric indications such as post-term pregnancy, preeclampsia, or fetal growth restriction. The primary objective is to achieve vaginal delivery while minimizing risks to both mother and child. Oxytocin, a synthetic analog of the natural hormone, is the most frequently used pharmacological agent for labor induction due to its effectiveness in promoting uterine contractions. However, its use is associated with complications, including uterine hyperstimulation, increased need for epidural analgesia, and higher rates of operative deliveries.

The potential of antispasmodics to aid in labor induction has been explored, with some studies indicating that these agents can reduce the duration of labor and enhance cervical dilation. The Cochrane review on antispasmodics for labor highlighted that these drugs, such as hyoscine butylbromide and drotaverine, could significantly reduce the duration of the first stage of labor and increase the rate of cervical dilation, although the overall quality of evidence was low. Despite these findings, further high-quality studies are recommended to substantiate these benefits and ensure safety.

Papaverine, a well-known smooth muscle relaxant traditionally used for treating vascular spasms, presents a promising adjunctive therapy for labor induction. By relaxing the smooth muscles of the cervix and uterus, papaverine may facilitate more efficient cervical ripening and enhance the effectiveness of oxytocin-induced contractions. Preliminary studies with other antispasmodics, such as butylscopolamine, have shown reductions in labor duration and improvements in labor progression without significant adverse effects, suggesting that papaverine might offer similar benefits.

This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone. The primary outcome will be the time to onset of active labor, with secondary outcomes including total duration of labor, rate of cesarean deliveries, maternal satisfaction, and adverse effects. By investigating this novel combination, the study seeks to provide new insights into optimizing labor induction protocols, ultimately improving maternal and neonatal outcomes.

Objective: To evaluate if adding papaverine to oxytocin reduces the time to active labor compared to oxytocin alone.

Design: a randomized controlled study Participants: Pregnant women at term requiring labor induction using oxytocin. Intervention Group: Combined use of papaverine (80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin) and oxytocin.

Control Group: Oxytocin plus 100 mL saline.

Primary outcome: Time to onset of active labor. Secondary outcomes: Total duration of labor, length of first stage of labor, length of second stage of labor, rate of cesarean deliveries, rate of cervical dilation.

Conditions

Induced; Birth; Labor Onset and Length Abnormalities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

oxytocin plus papaverine

Intervention Group: Combined use of papaverine (80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin) and oxytocin.

Group Type: ACTIVE_COMPARATOR

Papaverine

Intervention Type: DRUG

papaverine a smooth muscle relaxant

oxytocin alone

Control Group: Oxytocin plus 100 mL saline.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

normal saline 0.9% 100 cc

Interventions

Papaverine

papaverine a smooth muscle relaxant

Intervention Type: DRUG

normal saline

normal saline 0.9% 100 cc

Intervention Type: DRUG

Other Intervention Names

normal saline 0.9% 100 cc

Eligibility Criteria

Inclusion Criteria

• Women with a singleton pregnancy Over the age of 18 Term (between 37-42 weeks of gestation) A medical decision for labor induction using oxytocin. Cephalic presentation Viable fetus nulliparity

Exclusion Criteria

• parity >1
• Twin pregnancy Women with a previous cesarean section Severe fetal anomalies Women with psychiatric disorders, including depression and schizophrenia. Contraindication to vaginal delivery Women unable to sign the consent form Women known to have SVT (supraventricular tachycardia). Women with a heart rate over 100 or arrhythmia Known sensitivity to any component of the drug Liver disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Inshirah Sgayer

DR inshirah sgayer galilee medical center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

inshirah sgayer

Role: CONTACT

inshirah.sg.sh@gmail.com

0508890662

Other Identifiers

0124-24-NHR

Identifier Type: -

Identifier Source: org_study_id