Effect of Acidic Vaginal pH on the Efficacy of Dinoprosto... | NCT05100264

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

NCT05100264

Sponsor

Alexandra Hospital, Athens, Greece

Status

Completed

Last Update Posted

Feb 20, 2024Actual

Enrollment

230Actual

Phase

Not Applicable

Conditions

Labor, Induced
Induced; Birth

Interventions

Vaginal washing with 5% acetic acid
Vaginal washing with 0.9% NS

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2021Actual

Primary Completion Date

Dec 29, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

Oct 18, 2021

First Submission Date that Met QC Criteria

Oct 28, 2021

First Posted Date

Oct 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2024

Last Update Posted Date

Feb 20, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Georgios Daskalakis, Professor of Obstetrics and Gynecology, Alexandra Hospital, Athens, GreecePrincipal Investigator

Lead Sponsor

Alexandra Hospital, Athens, GreeceOTHER

Collaborators

Name	Class
National and Kapodistrian University of Athens	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interval from induction to delivery	Time interval (minutes)	36 hours

Secondary Outcomes

Measure	Description	Time Frame
Interval from induction to active labor	Time interval (minutes)	36 hours
Interval from induction to second stage of labor	Time interval (minutes)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georgios Daskalakis	Alexandra General Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandra General Hospital		Athens		11528	Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019342	Acetic Acid

Ancestor Terms

ID	Term
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Quadruple

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.

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor