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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03119155
Other study ID # FCHD-CHINA01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date December 31, 2021

Study information

Verified date August 2018
Source Beijing Anzhen Hospital
Contact Yihua He, MD
Phone +86 18910778673
Email heyihuaecho@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 1. Pregnant women with serious pregnancy complications and suffering from mental illness.

- 2.Pregnant women not willing to cooperate

Study Design


Locations

Country Name City State
China Beijng Anzhen Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the rate of missed diagnosis and misdiagnosis We will report the primary outcome every year, and compare the change trend of diagnostic level of fetal congenital heart disease From Jan 2018 to Dec 2020
Secondary The prognosis of different type of fetal congenital heart disease with 1 year after birth We will get the abortion rate of different types of fetal congenital heart disease and operation rate within 1 year after birth. From Jan 2018 to Dec 2021
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