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

Labor, Induced Clinical Trial

Official title:

Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone (PGE2) Vaginal Tablet for Labor Induction in Full Term Pregnant Women: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05100264
• Other study ID #: 68/7/22-9-21
• Status: Completed
• Phase: N/A
• Start date: October 29, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2024
• Source: Alexandra Hospital, Athens, Greece
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 30, 2022
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion criteria

• Singleton pregnancy

• Full term (>37 weeks)

• Cephalic presentation

• Reactive NST (nonstress test)

• Absence of spontaneous uterine contractions

• No contraindications to vaginal delivery

Exclusion criteria

• Multifetal pregnancy

• Fetal malpresentation

• Preterm delivery (<37 weeks)

• Advanced maternal age (>40 years)

• Bishop score > 7

• Fetal macrosomia ( >4500 gr)

• Non reassuring NST (nonstress test)

• Suspected chorioamnionitis

• Previous cesarean delivery or other uterine surgery

Related Conditions & MeSH terms

• Induced; Birth
• Labor, Induced

Intervention

Other:
• Vaginal washing with 5% acetic acid
Induction of labor (vaginal tablet dinoprostone and vaginal washing with 5% acetic acid)
• Vaginal washing with 0.9% NS
Induction of labor (vaginal tablet dinoprostone and vaginal washing 0.9% NS)

Locations

Country	Name	City	State
Greece	Alexandra General Hospital	Athens

Sponsors (2)

Lead Sponsor	Collaborator
Alexandra Hospital, Athens, Greece	National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interval from induction to delivery	Time interval (minutes)	36 hours
Secondary	Interval from induction to active labor	Time interval (minutes)	36 hours
Secondary	Interval from induction to second stage of labor	Time interval (minutes)	36 hours
Secondary	Failure of induction of labor	Rate of participants with failure of induction of labor	36 hours