Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,100
- Locations
- 1
- Primary Endpoint
- Presence/absence of a vaginal lesion due to delivery
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 15 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
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.
Intervention: Bacteriological analysis of vaginal sample (Biological)
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.
Intervention: Bacteriological analysis of vaginal sample (Biological)
Outcomes
Primary Outcomes
Presence/absence of a vaginal lesion due to delivery
Time Frame: Upon delivery (Day 0)
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
- Recorded qualitative and quantitative analysis of vaginal flora in patient's file(Upon delivery (Day 0))