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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02914392

Enrollment

600

Registered

2016-09-26

Start date

2017-05-18

Completion date

2020-12-31

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

case control study, Environmental Factors, Fetal Congenital Heart Disease

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Fetal Congenital heart disease	Sep 2016 to Jul 2018

Countries

China

Contacts

Primary ContactChen Sun, MD

chengsun@hotmail.com8621-25078485

Outcome results