The Application Value of STIC in the Diagnosis of Fetal Complex Congenital Heart Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

265 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-25

Study Completion Date

2020-12-31

Brief Summary

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The objective of this study is to use of STIC technology to assist the traditional echocardiography to diagnose the fetal congenital heart disease accurately and then to provide a basis for prenatal counseling.

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Detailed Description

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This is a diagnostic test in Shanghai Xinhua hospital from Nov.2016 to Dec.2017. 265 Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography.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.We collect their fetal 2D echocardiography and STIC images every 4-6 weeks during pregnancy and 1 weeks after the baby giving birth we finish their neonatal echocardiography.

Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Fetal congenital heart disease cases

Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Gravida with singleton pregnancy taking fetal echocardiography.
2. No virus infection or drug use history, no harmful substances in the early pregnancy.
3. Complete pregnancy check in the hospital, and finally delivery or abortion in the hospital.
4. On the basis of informed consent，willing to cooperate with our group.

Exclusion Criteria

1. Elderly pregnant women (\>35 years old)
2. Twin or multiple pregnancy
3. Pregnant women suffering from mental illness, can't take care of themselves.
4. Fetus diagnosed with other abnormalities (except congenital heart defects)

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes