Papaverine and Oxytocin vs Oxytocin Alone in Labor Induction

NCT06547437 | Not Yet Recruiting

• 1 other identifier: 0124-24-NHR
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Induced; Birth; Labor Onset and Length Abnormalities

Outcome Measures

Primary Outcomes (1)

• time to active delivery

  time from labor induction till dilatation of 6 cm

  24 HOURS AFTER DELIVERY

Secondary Outcomes (4)

• vaginal deliveries in 24 hours

  24 HOURS AFTER DELIVERY

• total length of labor

  24 HOURS AFTER DELIVERY

• cesarean delivery rate

  ho24 HOURS AFTER DELIVERY

• length of second stage of labor

  24 hours after delivery

Study Arms (2)

oxytocin plus papaverine

ACTIVE COMPARATOR

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

oxytocin alone

PLACEBO COMPARATOR

Control Group: Oxytocin plus 100 mL saline.

Drug: normal saline

Interventions

Papaverine DRUG

papaverine a smooth muscle relaxant

oxytocin plus papaverine

normal saline DRUG

normal saline 0.9% 100 cc

Also known as: normal saline 0.9% 100 cc

oxytocin alone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

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

Central Study Contacts

inshirah sgayer

CONTACT

0508890662; inshirah.sg.sh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR inshirah sgayer galilee medical center

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 9, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09