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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-center Clinical Study on the Relationship Between Maternal Exposure to Important Environmental Factors and Fetal Congenital Heart Disease

Conditions
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Congenital Heart Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gravida with singleton pregnancy taking fetal echocardiography in 16th-29nd of gestational weeks. 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. Exclusion Criteria: Pregnant women with serious pregnancy complications . 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fetal congenital heart disease cases<br>Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography | |
| Matched Controls for fetal congenital heart disease cases<br>Gravidas without fetal congenital heart disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal Congenital heart disease |  | Sep 2016 to Jul 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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case control study, Environmental Factors, Fetal Congenital Heart Disease