Peking University Birth Cohort in Tongzhou (PKUBC-T)

The PKUBC-T is a prospective cohort study carried out in Tongzhou district of Beijing, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to 6 years old. Biological samples including blood and tissue samples are also collected from mothers and their children.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Anemia; Preterm Birth; Child Development; Gestational Diabetes; Mother-Infant Interaction; Gestational Hypertension; Pregnancy Outcomes; Health Problems in Pregnancy
• Intervention / Treatment: Other: No intervention

Detailed Description

Maternal and child health is of great concern globally. Early life phase of a fetus and infant is a critical period for the development of health and disease in the whole life. Exposure of negative environmental, nutritional and lifestyle factors in pregnant women during this period can have adverse effects on fetal and infant. In addition, for mothers, complications during pregnancy could also have a negative effect on long-term health of mothers, such as diabetes, hypertension. Thus, the Peking University Birth Cohort in Tongzhou is primarily aimed to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to 6 years old. Biological samples including blood and tissue samples are also collected from mothers and their children.

• Study Type: Observational
• Enrollment (Estimated): 5426

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women and their children in Tongzhou, China

Description

Inclusion Criteria:

1. Pregnant women, <14 gestational weeks
2. Resided in Tongzhou in the past half years and have no plan to move out after delivery
3. Pregnant women who plan to have antenatal care and delivery in Tongzhou maternal&Child Hospital.
4. Pregnant women who is willing to participate in this study with informed consent

Exclusion Criteria:

Pregnant women have chronic disease before pregnancy, including diabetes，hypertension, liver disease and kidney disease.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposure group; Group with environmental, nutritional or lifestyle exposures	Other: No intervention; This is an observational study without any intervention
Non-exposed group; Group without any environmental, nutritional and lifestyle exposures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of participants with pregnancy complications	Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy	At delivery
Numbers of participants with adverse pregnancy outcomes	Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.	At delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in kilogram changes during childhood	Measured by health professionals in clinic	At birth and age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
Height in centimeter changes during childhood	Measured by health professionals in clinic	At birth and age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
Early Child development 1	Measured by Ages&Stages Questionnaires (ASQ).There are 6 questions in each of 5 domains of development: communication, gross motor, fine motor, problem-solving skills, and adaptive skills. Each question is given a 10 (yes), 5 (sometimes), or 0 (not yet) score according to the parents' answers. The sum scores (range from 0 to 300) and scores for each domain (range from 0 to 60) are calculated. Chinese norms are available for each domain, and any domain screened <2 SDs below the mean is considered a positive screening. A higher ASQ score means better development.	Age at 6 weeks and 3 years
Early Child development 2	Measured by Denver Developmental Screening Test (DDST). DDST comprises 125 test items grouped into four domains of child development: 25 personal-social (PS), 29 fine motor (FM), 39 language (LA) and 32 gross motor (GM). These test items are administered using a bell, glass bottle, set of 10 blocks, rattle, pencil, tennis ball, yarn, raisins, cup, white doll, white paper, and baby bottle. A child's raw score on each test item is marked as tested pass, failure, refusal, or no opportunity. The result of the test is labeled as "normal," "suspect" or "abnormal". Normal development means that there is no delay or at the maximum one warning. Abnormal development means that there is one or more than one delay situation. Suspicious development means that it is a situation involving one delay, one delay and one warning or two or more than two warnings. The number of children with normal, suspect or abnormal development is calculated.	Age at 8-12 months
Incidence of diabetes mellitus in women	Measured by health professionals in clinic	6 weeks after delivery and 3 years after delivery
Incidence of hypertension in women	Measured by health professionals in clinic	6 weeks after delivery and 3 years after delivery
Incidence of child overweight and obesity	Measured by health professionals in clinic	Age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
The proportion of children with warning signs	Measured by warning signs screening	Age at 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
Fetal Biparietal Diameter	Measured by health professionals in clinic with ultrasound	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Head Circumference	Measured by health professionals in clinic with ultrasound	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Abdominal Circumference	Measured by health professionals in clinic with ultrasound	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Femur Length	Measured by health professionals in clinic with ultrasound	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Humerus Length	Measured by health professionals in clinic with ultrasound	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: National Natural Science Foundation of China
• Investigators: Principal Investigator: Haijun Wang, Ph.D, Peking University

Publications and helpful links

General Publications

• Jin C, Lin L, Han N, Zhao Z, Liu Z, Luo S, Xu X, Liu J, Wang H. Effects of dynamic change in fetuin-A levels from the first to the second trimester on insulin resistance and gestational diabetes mellitus: a nested case-control study. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e000802. doi: 10.1136/bmjdrc-2019-000802.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): August 27, 2019
• Study Completion (Estimated): August 28, 2025

Study Registration Dates

• First Submitted: January 16, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Hypertension; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Diabetes, Gestational; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: NNSF81703240; 81703240 (Other Grant/Funding Number: The National Natural Science Fund)

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