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

Congenital Heart Disease Clinical Trial

— STIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02970071
• Other study ID #: XH-16-036
• Status: Recruiting
• Start date: April 25, 2017
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Chen Sun, MD
• Phone: 8621-25078485
• Email: chengsun[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 265
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
China	Xinhua Hospital,Shanghai Jiao Tong University School of Medicine	Yangpu	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (3)

DeVore GR, Falkensammer P, Sklansky MS, Platt LD. Spatio-temporal image correlation (STIC): new technology for evaluation of the fetal heart. Ultrasound Obstet Gynecol. 2003 Oct;22(4):380-7. — View Citation

Kim N, Friedberg MK, Silverman NH. Diagnosis and prognosis of fetuses with double outlet right ventricle. Prenat Diagn. 2006 Aug;26(8):740-5. — View Citation

Wren C, Reinhardt Z, Khawaja K. Twenty-year trends in diagnosis of life-threatening neonatal cardiovascular malformations. Arch Dis Child Fetal Neonatal Ed. 2008 Jan;93(1):F33-5. Epub 2007 Jun 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal Congenital heart disease	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.	Nov 2016 to Dec 2018