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Trial record 10 of 16941 for:    "Heart Diseases"

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

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ClinicalTrials.gov Identifier: NCT02970071
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease
Congenital Heart Disease

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.

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Study Type : Observational
Estimated Enrollment : 265 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Application Value of STIC in the Diagnosis of Fetal Complex Congenital Heart Disease
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort
Fetal congenital heart disease cases
Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Gravidas with singleton pregnancy living in SHANGHAI
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970071


Contacts
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Contact: Chen Sun, MD 8621-25078485 chengsun@hotmail.com
Contact: Sun Kun, MD

Locations
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China, Shanghai
Xinhua Hospital,Shanghai Jiao Tong University School of Medicine Recruiting
Yangpu, Shanghai, China, 200092
Principal Investigator: Sun Chen, MD         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Xinhua Hospital Shanghai Jiao Tong University School of Medicine Investigator

Publications of Results:
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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02970071     History of Changes
Other Study ID Numbers: XH-16-036
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Spatio-Temporal Image Correlation
Complicated congenital heart disease
Echocardiography

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities