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临床试验/NCT02673216
NCT02673216Unknown不适用

Infection and Adverse Pregnancy Outcome

Statens Serum Institut1 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2015年9月最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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