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

February 19, 2024 updated by: Georgios Daskalakis, Alexandra Hospital, Athens, Greece

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Georgios Daskalakis

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Alexandra General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaginal washing 5% acetic acid
Other: Vaginal washing with 5% acetic acid
Induction of labor (vaginal tablet dinoprostone and vaginal washing with 5% acetic acid)
Placebo Comparator: Vaginal washing 0.9% N/S
Other: Vaginal washing with 0.9% NS
Induction of labor (vaginal tablet dinoprostone and vaginal washing 0.9% NS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interval from induction to delivery
Time Frame: 36 hours
Time interval (minutes)
36 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interval from induction to active labor
Time Frame: 36 hours
Time interval (minutes)
36 hours
Interval from induction to second stage of labor
Time Frame: 36 hours
Time interval (minutes)
36 hours
Failure of induction of labor
Time Frame: 36 hours
Rate of participants with failure of induction of labor
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandra Hospital, Athens, Greece

Collaborators

National and Kapodistrian University of Athens

Investigators

  • Study Director: Georgios Daskalakis, Alexandra General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2021

Primary Completion (Actual)

December 29, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68/7/22-9-21

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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