Infection and Adverse Pregnancy Outcome
试验速览
- 阶段
- 不适用
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Preterm birth <37 weeks of gestation
研究概览
简要总结
Miscarriage (spontaneous abortion, stillbirth, and preterm birth) is the most common adverse out-come of pregnancy and a significant proportion is caused by infection. The investigators aim to study vaginal specimens from 1200 pregnant women recruited before 14 weeks of gestation with follow-up at mid-term (week 19) as well as 300 women aborting spontaneously. Adverse pregnancy outcome will be correlated to the presence of bacterial vaginosis (BV) subclasses, to vaginal fluid inflammation markers, and to the presence of novel Chlamydia-like bacteria, in particular Waddlia chondrophila. Species specific quantitative PCR assays for BV-related bacteria as well as next-generation-sequencing will be applied on selected specimens with the aim to identify markers allowing for a personalised treatment approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnancy
排除标准
- 未提供
结局指标
主要结局
Preterm birth <37 weeks of gestation
时间窗: 37 weeks of gestation
次要结局
未报告次要终点
