Birth Cohort Study of China Medical University

Study Overview
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Brief Summary
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The CMUBCS is a birth cohort study located in Shenyang, China. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Data are collected regarding environmental factors, family and lifestyle, clinical experimental outcomes and imaging results of pregnant women and children from birth to 18 years old. Biological samples including blood and tissue samples are also collected from the children and their parents.

Detailed Description
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Early life phase (fetal and infant) is a critical period for the development of health and disease in a person's life. Many adult chronic diseases, such as diabetes, cardiovascular and cerebrovascular diseases, all come from the exposure of negative environmental and behavioral factors during this period. By collecting the lifestyle data and clinical data of pregnant women at different periods, the appropriate indicators are anticipated to be selected to predict and evaluate the outcome of pregnancy and the health of the mothers and children in the long term. The status of overweight and obesity of children in Shenyang and its surrounding areas are anticipated to be analyzed by descriptive and etiological analysis through collecting the lifestyle data and clinical data of different periods of pregnant women and the lifestyle data of different developmental stages of children.

Official Title
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Birth Cohort Study of China Medical University in Shenyang

Conditions
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Twin; Complicating Pregnancy, Advanced Maternal Age Pregnancy, Scarred Uterus, Overweight and Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women, <13 gestational weeks Permanent residents or families intended to remain in Shenyang and surrounding areas Pregnant women who are planned to be examined and delivered in Shengjing Hospital. Exclusion Criteria: Pregnant women who refuse to take part in the study Pregnant women have diseases that might affect the results of researches, including neuropsychiatric disorders.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of biometric parameter in centimeter of fetuses at the thirteenth week of gestational age | Including head circumference, abdominal circumference, biparietal diameter, femur length of singleton and twin pregnancy | At every week from the thirteenth week of gestational age to delivery of babies | 
| Weight in kilogram of neonate | Including singleton and twin pregnancy measured by nurses | At birth of neonate | 
| Gene expression of husbands of pregnancy women | DNA methylation, histone acetylation etc. assessed by analyses of blood | At 13 weeks of gestational age | 
| Change of gene expression of pregnancy women | DNA methylation, histone acetylation etc. assessed by analyses of blood | At 13, 26 and 34 weeks of gestational age | 
| Result of Non-invasive Prenatal Testing | including singleton and twin pregnancy | From 12 to 22 weeks of gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of intestinal flora during early childhood | Assessed by analyses of stool samples | Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years | 
| Height in centimeter changes during childhood | Measured by nurses in clinic | Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years | 
| Weight in kilogram changes during childhood | Measured by nurses in clinic | Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years | 
| Change of gene expression during childhood | DNA methylation, histone acetylation etc. assessed by analyses of blood | Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years |