Peking University Birth Cohort in Weifang (PKUBC-WF)

Peking University Birth Cohort in Weifang

The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, 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 before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.

Study Overview

• Status: Not yet 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 Interventions

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 Weifang 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, husbands and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces samples are also collected.

• Study Type: Observational
• Enrollment (Estimated): 2800

Contacts and Locations

• Study Contact: Name: Haijun Wang, Ph.D; Phone Number: 86-010-82805583; Email: whjun1@bjmu.edu.cn
• Study Contact Backup: Name: Jue Liu, Ph.D; Phone Number: 86-13426455743; Email: jueliu@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University
      • Contact: Haijun Wang, Ph.D; Phone Number: 86-010-82805583; Email: whjun1@bjmu.edu.cn
      • Contact: Jue Liu, Ph.D; Phone Number: 86-13426455743; Email: jueliu@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women and their children in Weifang, China

Description

Inclusion Criteria:

• Pregnant woman

  1. Pregnant women, 6-13^+6 gestational weeks
  2. Resided in Weifang 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 Weifang maternal&Child Hospital.
  4. Pregnant women who is willing to participate in this study with informed consent

• Pregnant woman's husband

  1. His wife was eligible for enrollment
  2. He is the biological father of the child (his wife's current pregnancy)
  3. Pregnant women's husband who is willing to participate in this study with informed consent

• Offspring 4. Children born to pregnant women who met the inclusion criteria after enrolling in this study.

  5. Before the age of 8 years, his/her mother provided written informed consent. 6. After 8 years old, he/she agreed to continue this study and signed the informed consent.

Exclusion Criteria:

• Participants who cannot communicate normally.

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 Interventions; 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 and morbidity of participants with pregnancy complications	Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy	At delivery
Numbers and morbidity 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
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
Weight in kilogram changes during childhood	Measured by health professionals in clinic	At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years
Height in centimeter changes during childhood	Measured by health professionals in clinic	At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years
Early Child development	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, 6 months and 12 months
Incidence of child overweight and obesity	Measured by health professionals in clinic	At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years
Incidence of autism spectrum disorder in children	Measured by The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F) and Autism Behavior Checklist (ABC) scales	Age at 2 years, 3 years
Incidence of attention-deficit/hyperactivity disorder in children	Measured by The Child Behavior Checklist (CBC) scale	Age at 6 years
Incidence of anxiety in adolescents	Measured by Social Anxiety Scale for Adolescents (SAS-A) scale	Age at 9 years, 12 years, 15 years, and 17 years
Incidence of depression in adolescents	Measured by Beck Depression Inventory-II (BDI-II) scale	Age at 9 years, 12 years, 15 years, and 17 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2043

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

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: PKUBC-WF

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