NCT02970071

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 265 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Congenital Heart Disease

Timeline

• Start date: 2017-04-25
• Primary completion: 2018-12-01
• Completion: 2020-12-01
• First posted: 2016-11-21
• Last updated: 2018-10-26

Locations

1 site across 1 country: China