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CompletedNCT05100264Updated Feb 20, 2024

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

An interventional study of Vaginal washing with 5% acetic acid and Vaginal washing with 0.9% NS in Labor, Induced and Induced; Birth, sponsored by Alexandra Hospital, Athens, Greece. Completed at 1 site in Greece. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Alexandra Hospital, Athens, Greece · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Labor, Induced
  • Induced; Birth

Keywords

  • labor induction
  • dinoprostone
  • vaginal pH
03

In context

Lead sponsor

Alexandra Hospital, Athens, Greece is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
230 participants (actual)

Study arms

  • Experimental
    Vaginal washing 5% acetic acid

    Other: Vaginal washing with 5% acetic acid

  • Placebo comparator
    Vaginal washing 0.9% N/S

    Other: Vaginal washing with 0.9% NS

Interventions

  • OtherVaginal washing with 5% acetic acid

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

  • OtherVaginal washing with 0.9% NS

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

06

What researchers measure

Primary outcomes

  1. Interval from induction to delivery

    Time interval (minutes)

    Time frame: 36 hours

Secondary outcomes

  1. Interval from induction to active labor

    Time interval (minutes)

    Time frame: 36 hours

  2. Interval from induction to second stage of labor

    Time interval (minutes)

    Time frame: 36 hours

  3. Failure of induction of labor

    Rate of participants with failure of induction of labor

    Time frame: 36 hours

07

Study locations

1 site
  • Alexandra General Hospital
    Athens, 11528, Greece
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05100264
Lead sponsor
Alexandra Hospital, Athens, Greece
Collaborators
National and Kapodistrian University of Athens
Responsible party
Georgios Daskalakis (Professor of Obstetrics and Gynecology, Alexandra Hospital, Athens, Greece) — Principal investigator
First posted
Oct 29, 2021
Start date
Oct 29, 2021
Primary completion
Dec 29, 2022
Completion
Dec 30, 2022
Last update
Feb 20, 2024

Study contacts

Georgios Daskalakis
study director · Alexandra General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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