Clinical trial NCT02970071: The Application Value of STIC in the Diagnosis of Fetal Complex Congenital Heart Disease
Official title: The Application Value of STIC in the Diagnosis of Fetal Complex Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Keywords: Spatio-Temporal Image Correlation
Complicated congenital heart disease
Echocardiography
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 265
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gravidas with singleton pregnancy living in SHANGHAI

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fetal Congenital heart disease
timeFrame: Nov 2016 to Dec 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Yangpu
country: China
facility: Xinhua Hospital,Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Investigator
name: Xinhua Hospital Shanghai Jiao Tong University School of Medicine
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1136/adc.2007.119032. Epub 2007 Jun 7.
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. doi: 10.1002/pd.1500.
citation: 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.