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

Alexandra Hospital, Athens, Greece230 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

230

Conditions

Labor, Induced Induced; Birth

Interventions

Vaginal washing with 5% acetic acidOTHER

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

Vaginal washing with 0.9% NSOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Alexandra General Hospital

Athens, Greece

Outcomes

Primary Outcomes

Interval from induction to delivery

Time interval (minutes)

Time frame: 36 hours

Secondary Outcomes

Interval from induction to active labor

Time interval (minutes)

Time frame: 36 hours

Interval from induction to second stage of labor

Time interval (minutes)

Time frame: 36 hours

Failure of induction of labor

Rate of participants with failure of induction of labor

Time frame: 36 hours

Data from ClinicalTrials.gov

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