Peking University Birth Cohort in Weifang (PKUBC-WF)

Not yet recruiting

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

• Registration Number: NCT06234332
• Lead Sponsor: Peking University

Brief Summary

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.

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 Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31
• Study Start: 2024-02-01
• Primary Completion: 2026-12-31
• Study Completion: 2043-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Peking University; 🇨🇳 Beijing, Beijing, China