Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Presence/absence of a vaginal lesion due to delivery
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with a gestational age > 34 weeks delivering at the Nîmes University Hospital
排除标准
- •Patient under judicial protection
- •Adult patient under any kind of guardianship
- •Patient refuses participation
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Bacteriological analysis of vaginal sample (Biological)
结局指标
主要结局
Presence/absence of a vaginal lesion due to delivery
时间窗: Upon delivery (Day 0)
Record of abnormal vaginal flora (presence/absence of Nugent's score > 3) in patient's medical file
时间窗: Upon delivery (Day 0)
Record of routine analysis of vaginal samples during pregnancy will be used.
次要结局
- Recorded qualitative and quantitative analysis of vaginal flora in patient's file(Upon delivery (Day 0))