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

Sponsor

Alexandra Hospital, Athens, Greece (Other)

Overall Status

Recruiting

CT.gov ID

NCT05100264

Collaborator

National and Kapodistrian University of Athens (Other)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Labor, Induced Induced; Birth	Other: Vaginal washing with 5% acetic acid Other: Vaginal washing with 0.9% NS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 29, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaginal washing 5% acetic acid	Other: Vaginal washing with 5% acetic acid Induction of labor (vaginal tablet dinoprostone and vaginal washing with 5% acetic acid)
Placebo Comparator: Vaginal washing 0.9% N/S	Other: Vaginal washing with 0.9% NS Induction of labor (vaginal tablet dinoprostone and vaginal washing 0.9% NS)

Arm

Intervention/Treatment

Experimental: Vaginal washing 5% acetic acid

Other: Vaginal washing with 5% acetic acid

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

Placebo Comparator: Vaginal washing 0.9% N/S

Other: Vaginal washing with 0.9% NS

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

Outcome Measures

Primary Outcome Measures

Interval from induction to delivery [36 hours]
Time interval (minutes)

Secondary Outcome Measures

Interval from induction to active labor [36 hours]
Time interval (minutes)
Interval from induction to second stage of labor [36 hours]
Time interval (minutes)
Failure of induction of labor [36 hours]
Rate of participants with failure of induction of labor

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandra General Hospital	Athens		Greece	11528

Sponsors and Collaborators

Alexandra Hospital, Athens, Greece
National and Kapodistrian University of Athens

Investigators

Study Director: Georgios Daskalakis, Alexandra General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georgios Daskalakis, Professor of Obstetrics and Gynecology, Alexandra Hospital, Athens, Greece

ClinicalTrials.gov Identifier:

NCT05100264

Other Study ID Numbers:

68/7/22-9-21

First Posted:

Oct 29, 2021

Last Update Posted:

Dec 8, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Georgios Daskalakis, Professor of Obstetrics and Gynecology, Alexandra Hospital, Athens, Greece

labor induction

dinoprostone

vaginal pH

Additional relevant MeSH terms:

Acetic Acid

Retinol acetate

Study Results

No Results Posted as of Dec 8, 2021