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NCT Number: NCT05100264

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

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.

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Key information

Conditions

Labor, Induced Induced; Birth

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alexandra General Hospital

Athens, 11528, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal washing with 5% acetic acid

Other

Induction of labor (vaginal tablet dinoprostone and vaginal washing with 5% acetic acid)

Vaginal washing with 0.9% NS

Other

Induction of labor (vaginal tablet dinoprostone and vaginal washing 0.9% NS)

Primary outcomes

  1. Interval from induction to delivery

    Time frame: 36 hours

    Time interval (minutes)

Secondary outcomes

  1. Interval from induction to active labor

    Time frame: 36 hours

    Time interval (minutes)

  2. Interval from induction to second stage of labor

    Time frame: 36 hours

    Time interval (minutes)

  3. Failure of induction of labor

    Time frame: 36 hours

    Rate of participants with failure of induction of labor

Sponsors and collaborators

Lead sponsor

Alexandra Hospital, Athens, Greece

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2021
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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