Birth Cohort Study of China Medical University

Overweight and Obesity Clinical Trial

Official title:

Birth Cohort Study of China Medical University in Shenyang

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03561766
• Other study ID #: CMUBCS
• Status: Recruiting
• Start date: June 15, 2018
• Est. completion date: June 2037

Study information

• Verified date: December 2019
• Source: Shengjing Hospital
• Contact: Caixia Liu
• Phone: 86-18902451716
• Email: liucx1716[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2037
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Maternal Age Pregnancy
• Overweight
• Overweight and Obesity
• Pregnancy Complications
• Scarred Uterus
• Twin; Complicating Pregnancy

Locations

Country	Name	City	State
China	Shengjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Weight in kilogram of neonate	Including singleton and twin pregnancy measured by nurses	At birth of neonate
Primary	Gene expression of husbands of pregnancy women	DNA methylation, histone acetylation etc. assessed by analyses of blood	At 13 weeks of gestational age
Primary	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
Primary	Result of Non-invasive Prenatal Testing	including singleton and twin pregnancy	From 12 to 22 weeks of gestational age
Secondary	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
Secondary	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
Secondary	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
Secondary	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