Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale (PREMEVA2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Vaginal Microbiota pattern
研究概览
简要总结
Objective
To compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries
详细描述
Material and methods Case-control study nested in a cohort of pregnant patients in the first trimester. Inclusion criteria. : case is defined as spontaneous preterm births between 22 and 36 weeks in one of the 14 centers. The "control" patient will be considered as the following delivery over ≥ 37 weeks in the same center.
Multiple pregnancies, medical interruptions of pregnancy and deaths in utero will be excluded. Regarding the vaginal flora of cases and controls, the microorganisms will be researched and quantified by molecular methods.
Expected results
Patients and control patients will be compared for their demographic, obstetric, clinical and microbiological data. The parameters related to the risk of spontaneous prematurity at the p <0.20 threshold will then be analyzed by multi-level logistic regression.
Implications At a time when the link between bacterial vaginosis and prematurity is controversial, the detection - or not - of microorganisms linked to the risk of prematurity will be a key issue.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •case: spontaneous preterm births between 22 and 36 weeks in one of the 14 centers
- •controls : the following delivery over ≥ 37 weeks in the same center
排除标准
- •Multiple pregnancies, medical interruptions of pregnancy and deaths in utero
结局指标
主要结局
Vaginal Microbiota pattern
时间窗: 10 years
All microorganism potentially present in the vagina
次要结局
- Vaginal biological pattern(10 years)