Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?
Completed
- Conditions
- Vaginal Lesion
- Interventions
- Biological: Bacteriological analysis of vaginal sample
- Registration Number
- NCT01822782
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1100
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Controls Bacteriological analysis of vaginal sample 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. Cases Bacteriological analysis of vaginal sample 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.
- Primary Outcome Measures
Name Time Method Presence/absence of a vaginal lesion due to delivery Upon delivery (Day 0) Record of abnormal vaginal flora (presence/absence of Nugent's score > 3) in patient's medical file Upon delivery (Day 0) Record of routine analysis of vaginal samples during pregnancy will be used.
- Secondary Outcome Measures
Name Time Method Recorded qualitative and quantitative analysis of vaginal flora in patient's file Upon delivery (Day 0)
Trial Locations
- Locations (1)
CHU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 9, France