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Clinical Trials/NCT02914392
NCT02914392UnknownNot Applicable

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine2 sites in 1 country600 target enrollmentStarted: May 18, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
600
Locations
2
Primary Endpoint
Fetal Congenital heart disease

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Fetal Congenital heart disease

Time Frame: Sep 2016 to Jul 2018

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kun Sun

Director of Department of Pediatric Cardiology

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Sites (2)

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