Peking University Birth Cohort in Tongzhou

Active, not recruiting

• Conditions: Obesity; Health Problems in Pregnancy; Gestational Diabetes; Mother-Infant Interaction; Anemia; Preterm Birth; Child Development; Pregnancy Outcomes; Gestational Hypertension
• Interventions: Other: No intervention

• Registration Number: NCT03814395
• Lead Sponsor: Peking University

Brief Summary

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.

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 Timeline

• Study Start: 2018-06-28
• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-24
• Primary Completion: 2019-08-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Study Completion: 2025-08-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 5426

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposure group	No intervention	Group with environmental, nutritional or lifestyle exposures

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The proportion of children with warning signs	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	Measured by warning signs screening
Fetal Biparietal Diameter	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.	Measured by health professionals in clinic with ultrasound
Fetal Head Circumference	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.	Measured by health professionals in clinic with ultrasound
Fetal Femur Length	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.	Measured by health professionals in clinic with ultrasound
Fetal Humerus Length	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.	Measured by health professionals in clinic with ultrasound
Early Child development 1	Age at 6 weeks and 3 years	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.
Incidence of hypertension in women	6 weeks after delivery and 3 years after delivery	Measured by health professionals in clinic
Weight in kilogram changes during childhood	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	Measured by health professionals in clinic
Incidence of child overweight and obesity	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	Measured by health professionals in clinic
Fetal Abdominal Circumference	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.	Measured by health professionals in clinic with ultrasound
Height in centimeter changes during childhood	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	Measured by health professionals in clinic
Early Child development 2	Age at 8-12 months	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.
Incidence of diabetes mellitus in women	6 weeks after delivery and 3 years after delivery	Measured by health professionals in clinic

Trial Locations

Locations (1)

Peking University; 🇨🇳 Beijing, Beijing, China