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

NCT05100264 | Completed

• 1 other identifier: 68/7/22-9-21
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor, Induced; Induced; Birth

Keywords

labor induction; dinoprostone; vaginal pH

Outcome Measures

Primary Outcomes (1)

• Interval from induction to delivery

  Time interval (minutes)

  36 hours

Secondary Outcomes (3)

• 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

Study Arms (2)

Vaginal washing 5% acetic acid

EXPERIMENTAL

Other: Vaginal washing with 5% acetic acid

Vaginal washing 0.9% N/S

PLACEBO COMPARATOR

Other: Vaginal washing with 0.9% NS

Interventions

Vaginal washing with 5% acetic acid OTHER

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

Vaginal washing 5% acetic acid

Vaginal washing with 0.9% NS OTHER

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

Vaginal washing 0.9% N/S

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• Full term (\>37 weeks)
• Cephalic presentation
• Reactive NST (nonstress test)
• Absence of spontaneous uterine contractions
• No contraindications to vaginal delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandra Hospital, Athens, Greece: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Alexandra General Hospital

Athens, 11528, Greece

Location

MeSH Terms

Interventions

Acetic Acid

Intervention Hierarchy (Ancestors)

Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Georgios Daskalakis

  Alexandra General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 29, 2021
• Study Start: October 29, 2021
• Primary Completion: December 29, 2022
• Study Completion: December 30, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

GR (1)