Early Detection of Severe Heart Disease in Fetuses at High Risk of Heart
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 主要终点
- early ultrasound screening
研究概览
简要总结
The main objective of the work is to evaluate, in the French health care system, the performance of early ultrasound screening for severe heart disease between 11 and 14SA in high-risk populations.
详细描述
Numerous studies have shown a link between increased nuchal translucency and heart disease. Although high-risk fetal populations are identified between 11 and 13 SA on clinical and biological criteria and by screening ultrasound (Echo T1), cardiac morphology analysis is routinely performed only during 2nd trimester fetal morphology ultrasound between 18 and 22 SA (EchoMorpho-T2) inducing a difficult wait for the couple.
The development of increasingly efficient ultrasound probes has made it possible to explore the foetal heart at an earlier stage. International learned societies recommend an early morphological examination with heart-centered slices before 14 weeks in high-risk situations. This practice is not systematic in France and no study has evaluated its feasibility and impact in a French care network.
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 Months 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women whose fetus is at high risk for congenital heart disease:
- •Nuchal translucency measurement on T1 echo ≥3.5mm
- •Cardiac or extra-cardiac morphological abnormality suspected on the T1 screening echo
- •First degree family history for the fetus (patient, spouse, 1st children of the couple) of significant congenital cardiopathy (excluding AIC, muscular VIC or persistent CA).
排除标准
- •Multiple Pregnancies
- •non-emancipated minors, persons unable to express their consent.
- •Lack of affiliation to a social security scheme.
- •Subject in a period of exclusion from another study,
- •Subject under administrative or judicial supervision
- •Subject cannot be contacted in case of emergency
结局指标
主要结局
early ultrasound screening
时间窗: 1 day
Calculation of the sensitivity and specificity of screening for severe heart disease using EchoMorpho-T1. Specificity will be privileged in order to avoid the anxiety-producing nature of false positives.
次要结局
未报告次要终点