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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Vaginal Lesion

Treatments: Biological: Bacteriological analysis of vaginal sample

Study type: Observational

Funder types: Other

Identifiers

NCT01822782

LOCAL/2013/LB-01

Details and patient eligibility

About

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.

Enrollment: 1,100 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,100 participants in 2 patient groups

Cases

Description:

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.

Treatment:

Biological: Bacteriological analysis of vaginal sample

Controls

Description:

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.

Treatment:

Biological: Bacteriological analysis of vaginal sample