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

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

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.

Condition or disease
Congenital Heart Disease Echocardiography Diagnosis

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Improvement on Diagnosis of Fetal Congenital Heart Disease Based on Multi-center Collaboration in China
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Gravidas with singleton pregnancy with congenital heart disease
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119155


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

Locations
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China, Beijing
Beijng Anzhen Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Yanping Ruan, MD    +86 15311258732    yanping.ruan@163.com   
Sponsors and Collaborators
Beijing Anzhen Hospital
Additional Information:

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Responsible Party: He Yihua,MD, Director of Department of Ultrosound, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT03119155    
Other Study ID Numbers: FCHD-CHINA01
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by He Yihua,MD, Beijing Anzhen Hospital:
Congenital Heart Disease
Echocardiography
Diagnosis
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities