Birth Cohort Study of China Medical University

Birth Cohort Study of China Medical University in Shenyang

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity; Twin; Complicating Pregnancy; Scarred Uterus; Advanced Maternal Age Pregnancy

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Caixia Liu; Phone Number: 86-18902451716; Email: liucx1716@163.com
• Study Contact Backup: Name: Shaojiang Liu; Phone Number: 86-18002454803; Email: liushaojiang1995@qq.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shengjing Hospital
      • Contact: Shaowei Yin, PhD; Phone Number: 86-18902458403; Email: yinsw1984@163.com
      • Contact: Jiajin Hu, PhD; Phone Number: 86-18940287190; Email: 495403966@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women in Shenyang, China and their husband and children

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Principal Investigator: Caixia Liu, Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2018
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2037

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: June 17, 2018
• First Posted (ACTUAL): June 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight; Pregnancy Complications
• Other Study ID Numbers: CMUBCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No