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

• Conditions: Congenital Heart Disease

• Registration Number: NCT02970071
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-21
• Study Start: 2017-04-25
• Status Verified: 2018-09
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-26
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 265

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Xinhua Hospital,Shanghai Jiao Tong University School of Medicine; 🇨🇳 Yangpu, Shanghai, China