Clinical trial NCT03561766: Birth Cohort Study of China Medical University
Official title: Birth Cohort Study of China Medical University in Shenyang
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Twin; Complicating Pregnancy
Advanced Maternal Age Pregnancy
Scarred Uterus
Overweight and Obesity
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women in Shenyang, China and their husband and children

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women, \<13 gestational weeks
2. Permanent residents or families intended to remain in Shenyang and surrounding areas
3. Pregnant women who are planned to be examined and delivered in Shengjing Hospital.

Exclusion Criteria:

1. Pregnant women who refuse to take part in the study
2. Pregnant women have diseases that might affect the results of researches, including neuropsychiatric disorders.

Primary outcomes:
measure: Change of biometric parameter in centimeter of fetuses at the thirteenth week of gestational age
timeFrame: At every week from the thirteenth week of gestational age to delivery of babies
measure: Weight in kilogram of neonate
timeFrame: At birth of neonate
measure: Gene expression of husbands of pregnancy women
timeFrame: At 13 weeks of gestational age
measure: Change of gene expression of pregnancy women
timeFrame: At 13, 26 and 34 weeks of gestational age
measure: Result of Non-invasive Prenatal Testing
timeFrame: From 12 to 22 weeks of gestational age
Secondary outcomes:
measure: Change of intestinal flora during early childhood
timeFrame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
measure: Height in centimeter changes during childhood
timeFrame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
measure: Weight in kilogram changes during childhood
timeFrame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
measure: Change of gene expression during childhood
timeFrame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Caixia Liu
role: PRINCIPAL_INVESTIGATOR
References: