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临床试验/NCT03119155
NCT03119155Unknown不适用

Improvement on Diagnosis of Fetal Congenital Heart Disease Based on Multi-center Collaboration in China

Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5,000
试验地点
1
主要终点
the rate of missed diagnosis and misdiagnosis

研究概览

简要总结

The objective of this study is to improve the diagnosis level of fetal congenital heart disease by the multi-center collaboration in China.

详细描述

Our center has constructed multi-center collaborative network in 2013, so far which contains more than 170 maternal and child health care hospitals throughout the whole of China. This is a multi-center-based study to improve the integral diagnostic level of fetal congenital heart diseases by fetal echocardiography. Sixty pregnant cases (18-45 years) whose fetuses with heart abnormalities will be recruited in a successive manner from every center every year. Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography in 16th-24th of gestational weeks. Every center will upload the echocardiography materials and the diagnostic reports so that another two experienced echocardiography physicians confirm the diagnosis based on these materials in a double-blinded method. In addition, the golden standard of congenital heart disease depends on the autopsy, heart and vascular casting after abortion and operation after birth. The investigators will provide the report about the rate of missed diagnosis and misdiagnosis and the periodical training on fetal echocardiography for every center every half an year. Only gravidas who are willing to have complete pregnancy checks and finally delivery or abortion in the hospital are interviewed are eligible for the study. Study participants will be asked for their informed consent.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 1.Gravida with singleton pregnancy with congenital heart disease taking fetal echocardiography in 16th-24nd of gestational weeks.
  • 2.Complete pregnancy check in Beijing Anzhen Hospital and the hospitals contained in our multi-center network collaboration, and finally delivery or abortion in these hospitals.
  • 3.Willing to cooperate with our study.

排除标准

  • Pregnant women with serious pregnancy complications and suffering from mental illness.
  • 2.Pregnant women not willing to cooperate

结局指标

主要结局

the rate of missed diagnosis and misdiagnosis

时间窗: From Jan 2018 to Dec 2020

We will report the primary outcome every year, and compare the change trend of diagnostic level of fetal congenital heart disease

次要结局

  • The prognosis of different type of fetal congenital heart disease with 1 year after birth(From Jan 2018 to Dec 2021)

研究者

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

He Yihua,MD

Director of Department of Ultrosound

Beijing Anzhen Hospital

研究点 (1)

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