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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-29

Study Completion Date

2022-12-30

Brief Summary

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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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Detailed Description

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Conditions

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Labor, Induced Induced; Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Randomization will be computer generated. Allocation concealment will be ensured by opaque sealed envelopes. Blinding of outcomes assessor, principal as well as other investigators will be ensured as randomization will be performed by an external investigator that will not participate in the clinical process of the study or the statistical analysis. The ward midwife will open the randomization envelope after patient enrollment and different types of vaginal washing will be applied as per randomization. Participant as well outcomes assessor (physician that will evaluate the progress of labor as well statistician involved in the analysis) will be blinded to the procedure.

Study Groups

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Vaginal washing 5% acetic acid

Group Type EXPERIMENTAL

Vaginal washing with 5% acetic acid

Intervention Type OTHER

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

Vaginal washing 0.9% N/S

Group Type PLACEBO_COMPARATOR

Vaginal washing with 0.9% NS

Intervention Type OTHER

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

Interventions

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Vaginal washing with 5% acetic acid

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

Intervention Type OTHER

Vaginal washing with 0.9% NS

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes