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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01822782
Enrollment
1100
Registered
2013-04-02
Start date
2013-06-30
Completion date
2013-12-06
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Lesion

Keywords

Perineal tear, Perineal lesion, Vaginal flora, Birth

Brief 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.

Interventions

BIOLOGICALBacteriological analysis of vaginal sample

Bacteriological analysis of vaginal sample

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence/absence of a vaginal lesion due to deliveryUpon delivery (Day 0)
Record of abnormal vaginal flora (presence/absence of Nugent's score > 3) in patient's medical fileUpon delivery (Day 0)Record of routine analysis of vaginal samples during pregnancy will be used.

Secondary

MeasureTime frame
Recorded qualitative and quantitative analysis of vaginal flora in patient's fileUpon delivery (Day 0)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026