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

NCT ID: NCT01822782

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-06

Brief Summary

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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.

Detailed Description

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Conditions

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Vaginal Lesion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Bacteriological analysis of vaginal sample

Intervention Type 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.

Bacteriological analysis of vaginal sample

Intervention Type BIOLOGICAL

Bacteriological analysis of vaginal sample

Interventions

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Bacteriological analysis of vaginal sample

Bacteriological analysis of vaginal sample

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurie Becerra, Sage Femme

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Jean-Philippe Lavigne, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 26544959 (View on PubMed)

Other Identifiers

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LOCAL/2013/LB-01

Identifier Type: -

Identifier Source: org_study_id

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