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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02970071

Acronym

STIC

Enrollment

265

Registered

2016-11-21

Start date

2017-04-25

Completion date

2020-12-31

Last updated

2018-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

Spatio-Temporal Image Correlation, Complicated congenital heart disease, Echocardiography

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Fetal Congenital heart disease	Nov 2016 to Dec 2018	If an enrolled gravida chooses to terminate her pregnancy, autopsy confirmation will be performed ;If the gravida continues her pregnancy, the outcome will be measured by neonatal echocardiography or surgery.

Countries

China

Contacts

Primary ContactChen Sun, MD

chengsun@hotmail.com8621-25078485

Backup ContactSun Kun, MD

Outcome results