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临床试验/NCT04382222
NCT04382222Unknown不适用

Sensitivity and Accuracy of Prenatal Diagnosis of Severe Congenital Heart Diseases in the Antwerp Region

Universiteit Antwerpen1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,500
试验地点
1
主要终点
sensitivity and accuracy of prenatal ultrasound for cardiac malformations

研究概览

简要总结

No systematic research has been done in the last 15 years on the accuracy of prenatal ultrasound of congenital heart diseases in Belgium. Nor are there any population-based studies available on this subject for Belgium. Based on the data of EUROCAT (European Surveillance of Congenital Anomalies) the investigators analyse prenatal diagnostic sensitivity of congenital heart diseases in the EUROCAT regions Antwerp (Flanders, Belgium)

详细描述

Congenital heart defects are a leading cause of infant mortality with an incidence of 0,4-1,3% at birth. Although prenatal detection rates vary widely, morphological (structural) cardiac malformations are among the most frequently missed abnormalities by prenatal ultrasonography.

However, identifying fetal cardiac abnormalities early in pregnancy is essential. Early diagnosis allows extensive cardiac ultrasound, genetic testing and planning delivery in a paediatric-cardiac centre offering optimal neonatal care.

It also may allow the future parents to consider and decide for a termination of pregnancy in case of a severe fetal heart malformation with poor prognosis.

The investigator conducts a retrospective study on 2500 cases of congenital heart diseases over 20 years. Detailed data for this were made available by the EUROCAT Antwerp registry, a population-based database with controlled, reliable and robust data.

The study wants to reveal the prevalence and prenatal diagnostic sensitivity of congenital heart defects in the EUROCAT regions Antwerp (Flanders) and especially the evolution of the prenatal diagnostic rate over time.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

sensitivity and accuracy of prenatal ultrasound for cardiac malformations

时间窗: retrospective 20 years

retrospective analysis of prenatally missed and diagnosed congenital heart disaeses iseaersa

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Yves Jacquemyn

Professor

Universiteit Antwerpen

研究点 (1)

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