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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

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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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