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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03119155
• Other study ID #: FCHD-CHINA01
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Diagnosis
• Echocardiography
• Heart Defects, Congenital
• Heart Diseases

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