Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?

November 17, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

The main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery. For this, the primary endpoint will be the proportion of vaginal lesions according to the presence or absence of abnormal vaginal flora.

A more precise qualitative and quantitative study of vaginal flora isolated from pregnant women and its association with vaginal lesions will also be conducted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months.

Description

Inclusion Criteria:

  • Pregnant women with a gestational age > 34 weeks delivering at the Nîmes University Hospital

Exclusion Criteria:

  • Patient under judicial protection
  • Adult patient under any kind of guardianship
  • Patient refuses participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months. "Cases" are classified as those with a vaginal lesion due to delivery.
Biological: Bacteriological analysis of vaginal sample
Bacteriological analysis of vaginal sample
Controls
The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months. "Controls" are classified as those without a vaginal lesion due to delivery.
Biological: Bacteriological analysis of vaginal sample
Bacteriological analysis of vaginal sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence/absence of a vaginal lesion due to delivery
Time Frame: Upon delivery (Day 0)
Upon delivery (Day 0)
Record of abnormal vaginal flora (presence/absence of Nugent's score > 3) in patient's medical file
Time Frame: Upon delivery (Day 0)
Record of routine analysis of vaginal samples during pregnancy will be used.
Upon delivery (Day 0)

Secondary Outcome Measures

Outcome Measure
Time Frame
Recorded qualitative and quantitative analysis of vaginal flora in patient's file
Time Frame: Upon delivery (Day 0)
Upon delivery (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Laurie Becerra, Sage Femme, Centre Hospitalier Universitaire de Nīmes
  • Study Director: Jean-Philippe Lavigne, MD, PhD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 6, 2013

Study Completion (Actual)

December 6, 2013

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (Estimated)

April 2, 2013

Study Record Updates

Last Update Posted (Estimated)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LOCAL/2013/LB-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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