Papaverine and Oxytocin vs Oxytocin Alone in Labor Induction

"Evaluating the Effectiveness of Papaverine as an Adjunct to Oxytocin for Labor Induction: A Randomized Controlled Trial"

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

Study Overview

• Status: Not yet recruiting
• Conditions: Labor Onset and Length Abnormalities; Induced; Birth
• Intervention / Treatment: Drug: Papaverine; Drug: normal saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: inshirah sgayer; Phone Number: 0508890662; Email: inshirah.sg.sh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Papaverine; papaverine a smooth muscle relaxant
Placebo Comparator: oxytocin alone; Control Group: Oxytocin plus 100 mL saline.	Drug: normal saline; normal saline 0.9% 100 cc; Other Names: normal saline 0.9% 100 cc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to active delivery	time from labor induction till dilatation of 6 cm	24 HOURS AFTER DELIVERY

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vaginal deliveries in 24 hours	rate of vaginal deliveries in 24 hours	24 HOURS AFTER DELIVERY
total length of labor	time for induction to delivery	24 HOURS AFTER DELIVERY
cesarean delivery rate	rate of emergent cesarean delivery during labor	ho24 HOURS AFTER DELIVERY
length of second stage of labor	second stage of labor in hours	24 hours after delivery

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 10, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Papaverine
• Other Study ID Numbers: 0124-24-NHR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No