NCT03119155

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

April 13, 2017

Last Update Submit

August 17, 2018

Conditions

Congenital Heart DiseaseEchocardiographyDiagnosis

Keywords

Congenital Heart DiseaseEchocardiographyDiagnosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The prognosis of different type of fetal congenital heart disease with 1 year after birth

    From Jan 2018 to Dec 2021

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Gravidas with singleton pregnancy with congenital heart disease

You may qualify if:

  • Gravida with singleton pregnancy with congenital heart disease taking fetal echocardiography in 16th-24nd of gestational weeks.
  • 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.
  • Willing to cooperate with our study.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijng Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Heart Defects, CongenitalDisease

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yihua He, MD

CONTACT

+86 18910778673heyihuaecho@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Ultrosound

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 18, 2017

Study Start

December 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

August 20, 2018

Record last verified: 2018-08

Locations

CN(1)