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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02914392
• Other study ID #: XH-16-023
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2016
• Last updated: January 20, 2018
• Start date: May 18, 2017
• Est. completion date: December 2020

Study information

• Verified date: January 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Chen Sun, MD
• Phone: 8621-25078485
• Email: chengsun[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2020
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
China	School of environmental science and engineering, Shanghai jiaotong university	Shanghai
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal Congenital heart disease		Sep 2016 to Jul 2018