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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Congenital Heart Disease

Study type

Observational

Funder types

Other

Identifiers

NCT02970071
XH-16-036

Details and patient eligibility

About

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.

Full description

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.

Enrollment

265 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

265 participants in 1 patient group

Fetal congenital heart disease cases
Description:
Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography

Trial contacts and locations

1

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Central trial contact

Sun Kun, MD; Chen Sun, MD

Data sourced from clinicaltrials.gov

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