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CompletedNCT01822782Updated Nov 19, 2025

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

An observational study in Vaginal Lesion, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to female participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,100
Ages
15 Years to 45 Years
Sex
Female
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Study summary

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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Conditions studied

  • Vaginal Lesion

Keywords

  • Perineal tear
  • Perineal lesion
  • Vaginal flora
  • Birth
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In context

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

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

04

Who can participate

Ages eligible
15 Years to 45 Years
Sexes eligible
Female
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • BiologicalBacteriological analysis of vaginal sample

    Bacteriological analysis of vaginal sample

06

What researchers measure

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

    Record of routine analysis of vaginal samples during pregnancy will be used.

    Time frame: Upon delivery (Day 0)

Secondary outcomes

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

    Time frame: Upon delivery (Day 0)

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Study locations

1 site
  • CHU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes, 30029, France
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References and documents

Publications

  • Letouzey V, Bastide S, Ulrich D, Beccera L, Lomma M, de Tayrac R, Lavigne JP. Impact of Bacterial Vaginosis on Perineal Tears during Delivery: A Prospective Cohort Study. PLoS One. 2015 Nov 6;10(11):e0139334. doi: 10.1371/journal.pone.0139334. eCollection 2015. PubMed 26544959 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01822782
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Apr 2, 2013
Start date
Jun 2013
Primary completion
Dec 6, 2013
Completion
Dec 6, 2013
Last update
Nov 19, 2025

Study contacts

Laurie Becerra, Sage Femme
principal investigator · Centre Hospitalier Universitaire de Nīmes
Jean-Philippe Lavigne, MD, PhD
study director · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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