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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-18

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Fetal congenital heart disease cases

Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography

No interventions assigned to this group

Matched Controls for fetal congenital heart disease cases

Gravidas without fetal congenital heart disease

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes