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Clinical Trials/NCT05100264
NCT05100264CompletedNot Applicable

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

Alexandra Hospital, Athens, Greece2 sites in 1 country230 target enrollmentStarted: October 29, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
230
Locations
2
Primary Endpoint
Interval from induction to delivery

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Vaginal washing 5% acetic acid

Experimental

Intervention: Vaginal washing with 5% acetic acid (Other)

Vaginal washing 0.9% N/S

Placebo Comparator

Intervention: Vaginal washing with 0.9% NS (Other)

Outcomes

Primary Outcomes

Interval from induction to delivery

Time Frame: 36 hours

Time interval (minutes)

Secondary Outcomes

  • Interval from induction to active labor(36 hours)
  • Interval from induction to second stage of labor(36 hours)
  • Failure of induction of labor(36 hours)

Investigators

Sponsor
Alexandra Hospital, Athens, Greece
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Georgios Daskalakis

Professor of Obstetrics and Gynecology

Alexandra Hospital, Athens, Greece

Study Sites (2)

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