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

• ClinicalTrials.gov Identifier: NCT03119155
• Recruitment Status: Recruiting
• First Posted: April 18, 2017
• Last Update Posted: August 20, 2018
• Sponsor: Beijing Anzhen Hospital
• Information provided by (Responsible Party): He Yihua,MD, Beijing Anzhen Hospital

Tracking Information

• First Submitted Date: April 13, 2017
• First Posted Date: April 18, 2017
• Last Update Posted Date: August 20, 2018
• Estimated Study Start Date: December 1, 2018
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 13, 2017)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 13, 2017)

The prognosis of different type of fetal congenital heart disease with 1 year after birth [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Improvement on Diagnosis of Fetal Congenital Heart Disease Based on Multi-center Collaboration in China
• Official Title: Improvement on Diagnosis of Fetal Congenital Heart Disease Based on Multi-center Collaboration in China
• 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.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Only; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 2 Years
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Gravidas with singleton pregnancy with congenital heart disease

Condition

• Congenital Heart Disease
• Echocardiography
• Diagnosis

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 18, 2017): 5000
• Original Estimated Enrollment (submitted: April 13, 2017): 1000
• Estimated Study Completion Date: December 31, 2021
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

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:

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Yihua He, MD; +86 18910778673; heyihuaecho@hotmail.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03119155
• Other Study ID Numbers: FCHD-CHINA01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: He Yihua,MD, Beijing Anzhen Hospital
• Study Sponsor: Beijing Anzhen Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Beijing Anzhen Hospital
• Verification Date: August 2018