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Trial record 15 of 16941 for:    "Heart Diseases"

Study on the Relationship Between Maternal Exposure to Environmental Factors and Fetal Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT02914392
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
The objective of this study is to research the relationship between maternal exposure to environmental factors and fetal congenital heart disease in a community-based case-control study.

Condition or disease
Congenital Heart Disease

Detailed Description:
This is a community-based case-control study in SHANGHAI,a municipality in CHINA. Cases will be identified from maternity centers. Matched controls will be accrued from the same region as the case came from. Pregnant cases and their controls are women (18-45 years). Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography in 16th-29nd of gestational weeks. Controls are pregnant women without fetal congenital heart disease diagnosis. 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. About 2 controls matched by year of birth and region will be allocated to each case. A standardized questionnaire will be used for all cases and controls. Field investigations are also conducted for them by quantitative measurement of some chemical, physical and nutritional factors related indicators may affect fetal cardiovascular development. Study participants will be asked for their informed consent.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Multi-center Clinical Study on the Relationship Between Maternal Exposure to Important Environmental Factors and Fetal Congenital Heart Disease
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : July 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
Matched Controls for fetal congenital heart disease cases
Gravidas without fetal congenital heart disease



Primary Outcome Measures :
  1. Fetal Congenital heart disease [ Time Frame: Sep 2016 to Jul 2018 ]

Biospecimen Retention:   Samples Without DNA
The content of folic acid in serum of cases and controls is determined.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 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 in 16th-29nd of gestational weeks.
  2. Complete pregnancy check in the hospital, and finally delivery or abortion in the hospital.
  3. On the basis of informed consent,willing to cooperate with our group.

Exclusion Criteria:

  1. Pregnant women with serious pregnancy complications .
  2. Pregnant women suffering from mental illness, can't take care of themselves. 3) Fetus diagnosed with chromosomal abnormalities in pregnant women .

4)Repeated explanation does not cooperate in pregnant women.


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): NCT02914392


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

Locations
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China, Shanghai
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China
Contact: Chen Sun    8621-25078485      
Principal Investigator: Sun Jing         
China
School of environmental science and engineering, Shanghai jiaotong university Active, not recruiting
Shanghai, China
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Kun Sun, MD Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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Responsible Party: Kun Sun, Director of Department of Pediatric Cardiology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02914392     History of Changes
Other Study ID Numbers: XH-16-023
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
case control study
Environmental Factors
Fetal Congenital Heart Disease

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