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

NCT02970071 | Unknown DMC

• 1 other identifier: XH-16-036
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fetal congenital heart disease cases

Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Gravidas with singleton pregnancy living in SHANGHAI

You may qualify if:

• Gravida with singleton pregnancy taking fetal echocardiography.
• No virus infection or drug use history, no harmful substances in the early pregnancy.
• Complete pregnancy check in the hospital, and finally delivery or abortion in the hospital.
• On the basis of informed consent，willing to cooperate with our group.

You may not qualify if:

• Elderly pregnant women (\>35 years old)
• Twin or multiple pregnancy
• Pregnant women suffering from mental illness, can't take care of themselves.
• Fetus diagnosed with other abnormalities (except congenital heart defects)

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital,Shanghai Jiao Tong University School of Medicine

Yangpu, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 17556383 RESULT

• 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.

  PMID: 16807954 RESULT

• 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.

  PMID: 14528474 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xinhua Hospital Shanghai Jiao Tong University School of Medicine

  Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Sun, MD

CONTACT

8621-25078485; chengsun@hotmail.com

Sun Kun, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 21, 2016
• Study Start: April 25, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: October 26, 2018

Record last verified: 2018-09

Locations

CN (1)