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OpenTrials
Completed

NCT Number: NCT01822782

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

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.

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Key information

Conditions

Vaginal Lesion

Age range

15 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bacteriological analysis of vaginal sample

Biological

Bacteriological analysis of vaginal sample

Primary outcomes

  1. Presence/absence of a vaginal lesion due to delivery

    Time frame: Upon delivery (Day 0)

  2. 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.

Secondary outcomes

  1. Recorded qualitative and quantitative analysis of vaginal flora in patient's file

    Time frame: Upon delivery (Day 0)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2013
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.