NCT02914392

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
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Congenital Heart Disease

Timeline

• Start date: 2017-05-18
• Primary completion: 2018-07-01
• Completion: 2020-12-01
• First posted: 2016-09-26
• Last updated: 2018-01-23

Locations

2 sites across 1 country: China