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Clinical Trials/NCT03119155
NCT03119155
Unknown
Not Applicable

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

Beijing Anzhen Hospital1 site in 1 country5,000 target enrollmentDecember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Beijing Anzhen Hospital
Enrollment
5000
Locations
1
Primary Endpoint
the rate of missed diagnosis and misdiagnosis
Last Updated
7 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
December 31, 2021
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Beijing Anzhen Hospital
Responsible Party
Principal Investigator
Principal Investigator

He Yihua,MD

Director of Department of Ultrosound

Beijing Anzhen Hospital

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

the rate of missed diagnosis and misdiagnosis

Time Frame: 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

Secondary Outcomes

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

Study Sites (1)

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