Clinical trial NCT02914392: Study on the Relationship Between Maternal Exposure to Environmental Factors and Fetal Congenital Heart Disease
Official title: Multi-center Clinical Study on the Relationship Between Maternal Exposure to Important Environmental Factors and Fetal Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Keywords: case control study
Environmental Factors
Fetal Congenital Heart Disease
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gravidas with singleton pregnancy living in SHANGHAI

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fetal Congenital heart disease
timeFrame: Sep 2016 to Jul 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: School of environmental science and engineering, Shanghai jiaotong university
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Kun Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: