Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Early diagnosis of preterm birth using vaginal microbiota analysis
研究概览
简要总结
Objectives: to assess the relevance of the RiboTaxa algorithm coupled with neural network learning based on analysis of vaginal microbiota metagenomic sequencing data for predicting prematurity in an identified at-risk population.
Study description: Longitudinal follow-up of a cohort of pregnant women, with collection of biological samples, and a posteriori case-control comparison based on the occurrence of an event (premature birth).
详细描述
There is currently no reliable clinical or biological diagnosis to predict premature birth. Recent work using metagenomic data analysis coupled with artificial intelligence approaches suggests that there may be a vaginal microbiota signature during pregnancy that correlates with the occurrence of preterm birth. The aim of the study is to use biological samples to confirm the identification of these vaginal microbiota signatures as a means of predicting preterm birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Pregnant women Admitted to the Clermont-Ferrand University Hospital maternity ward from 14 weeks' gestation onwards
- •For threat of preterm birth (PTB) characterized by contractile activity and/or cervical changes, or for premature rupture of fetal membranes (PROM)
- •And in need of vaginal swabbing
- •Single or multiple pregnancy
- •Able to understand and object to the study
- •Covered by a French social security scheme.
- •Give informed consent for the study
排除标准
- •Patient under guardianship, curatorship or safeguard of justice
- •Patient having received antibiotic therapy in the 2 weeks prior to admission
研究组 & 干预措施
cohort of pregnant women at -risk of preterm delivery
vaginal swab
干预措施: vaginal swab (Other)
结局指标
主要结局
Early diagnosis of preterm birth using vaginal microbiota analysis
时间窗: at birth
prematurity yes/no (define by birth \<37WG)
次要结局
未报告次要终点