Improvement on Diagnosis of Fetal Congenital Heart Disease Based on Multi-center Collaboration in China
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
- 否
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
He Yihua,MD
Director of Department of Ultrosound
Beijing Anzhen Hospital
