Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone for Labor Induction

Not Applicable

Completed

• Conditions: Labor, Induced; Induced; Birth
• Interventions: Other: Vaginal washing with 5% acetic acid; Other: Vaginal washing with 0.9% NS

• Registration Number: NCT05100264
• Lead Sponsor: Alexandra Hospital, Athens, Greece

Brief Summary

Acidification of vaginal pH has been proposed as a potential factor that could help increase the efficacy of vaginal prostaglandins in labor induction. The aim of the present randomized controlled trial is to evaluate the impact of an acidic vaginal pH on the progress of labor induction with dinoprostone (Prostaglandin E2 - PGE2) vaginal tablet.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-28
• Study Start: 2021-10-29
• Study First Posted: 2021-10-29
• Primary Completion: 2022-12-29
• Study Completion: 2022-12-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal washing 5% acetic acid	Vaginal washing with 5% acetic acid	-
Vaginal washing 0.9% N/S	Vaginal washing with 0.9% NS	-

Primary Outcome Measures

Name	Time	Method
Interval from induction to delivery	36 hours	Time interval (minutes)

Secondary Outcome Measures

Name	Time	Method
Interval from induction to active labor	36 hours	Time interval (minutes)
Interval from induction to second stage of labor	36 hours	Time interval (minutes)
Failure of induction of labor	36 hours	Rate of participants with failure of induction of labor

Trial Locations

Locations (1)

Alexandra General Hospital; 🇬🇷 Athens, Greece