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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03119155

Enrollment

5000

Registered

2017-04-18

Start date

2018-12-01

Completion date

2021-12-31

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Diagnosis, Echocardiography

Keywords

Congenital Heart Disease, Echocardiography, Diagnosis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
the rate of missed diagnosis and misdiagnosis	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

Measure	Time frame	Description
The prognosis of different type of fetal congenital heart disease with 1 year after birth	From Jan 2018 to Dec 2021	We will get the abortion rate of different types of fetal congenital heart disease and operation rate within 1 year after birth.

Countries

China

Contacts

Primary ContactYihua He, MD

heyihuaecho@hotmail.com+86 18910778673

Outcome results