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NCT Number: NCT06234332

Peking University Birth Cohort in Weifang (PKUBC-WF)

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.

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Key information

Conditions

Health Problems in Pregnancy Anemia Body Weight Cardiovascular Diseases Child Development Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Gestational Hypertension Glucose Metabolism Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hypertension Hypertension, Pregnancy-Induced Metabolic Diseases Mother-Infant Interaction Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obstetric Labor Complications Obstetric Labor, Premature Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Outcomes Premature Birth Preterm Birth Signs and Symptoms Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant woman
  • Pregnant women, 6-13^+6 gestational weeks
  • Resided in Weifang in the past half years and have no plan to move out after delivery
  • Pregnant women who plan to have antenatal care and delivery in Weifang maternal&Child Hospital.
  • Pregnant women who is willing to participate in this study with informed consent
  • Pregnant woman's husband
  • His wife was eligible for enrollment
  • He is the biological father of the child (his wife's current pregnancy)
  • 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.
  • 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.

Treatment and study plan

No interventions

Other

No intervention This is an observational study without any intervention

Primary outcomes

  1. Numbers and morbidity of participants with pregnancy complications

    Time frame: At delivery

    Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy

  2. Numbers and morbidity of participants with adverse pregnancy outcomes

    Time frame: At delivery

    Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.

Secondary outcomes

  1. Weight in kilogram changes during childhood

    Time frame: 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

  2. Height in centimeter changes during childhood

    Time frame: 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

  3. Early Child development

    Time frame: 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.

  4. Incidence of diabetes mellitus in women

    Time frame: 6 weeks after delivery and 3 years after delivery

    Measured by health professionals in clinic

  5. Incidence of hypertension in women

    Time frame: 6 weeks after delivery and 3 years after delivery

    Measured by health professionals in clinic

  6. Incidence of child overweight and obesity

    Time frame: 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

  7. Incidence of autism spectrum disorder in children

    Time frame: 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

  8. Incidence of attention-deficit/hyperactivity disorder in children

    Time frame: Age at 6 years

    Measured by The Child Behavior Checklist (CBC) scale

  9. Incidence of anxiety in adolescents

    Time frame: Age at 9 years, 12 years, 15 years, and 17 years

    Measured by Social Anxiety Scale for Adolescents (SAS-A) scale

  10. Incidence of depression in adolescents

    Time frame: Age at 9 years, 12 years, 15 years, and 17 years

    Measured by Beck Depression Inventory-II (BDI-II) scale

Study contacts

Contact information is provided by the study sponsor or research team.

Haijun Wang, Ph.D

CONTACT

[email protected]

86-010-82805583

Jue Liu, Ph.D

CONTACT

[email protected]

86-13426455743

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

Peking University Birth Cohort in Weifang

Important dates

Study start
2024
Primary completion
2026
Study completion
2043
First posted
Jan 31, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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