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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2018

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.

Arms, Groups and Cohorts

  • Fetal congenital heart disease cases
    • Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography

Clinical Trial Outcome Measures

Primary Measures

  • Fetal Congenital heart disease
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xinhua Hospital Shanghai Jiao Tong University School of Medicine, Principal Investigator, Investigator
  • Overall Contact(s)
    • Chen Sun, MD, 8621-25078485, chengsun@hotmail.com

Citations Reporting on Results

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. doi: 10.1136/adc.2007.119032. Epub 2007 Jun 7.

Kim N, Friedberg MK, Silverman NH. Diagnosis and prognosis of fetuses with double outlet right ventricle. Prenat Diagn. 2006 Aug;26(8):740-5. doi: 10.1002/pd.1500.

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. doi: 10.1002/uog.217.

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