NCT06234332

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,800

participants targeted

Target at P75+ for all trials

Timeline
214mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Feb 2024Dec 2043

First Submitted

Initial submission to the registry

January 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
17 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2043

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

2.9 years

First QC Date

January 23, 2024

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • 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

  • 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

  • Early Child development

    Age at 6 weeks, 6 months and 12 months

  • Incidence of diabetes mellitus in women

    6 weeks after delivery and 3 years after delivery

  • Incidence of hypertension in women

    6 weeks after delivery and 3 years after delivery

  • +5 more secondary outcomes

Study Arms (2)

Exposure group

Group with environmental, nutritional or lifestyle exposures

Other: No Interventions

Non-exposed group

Group without any environmental, nutritional and lifestyle exposures

Interventions

No intervention This is an observational study without any intervention

Exposure group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women and their children in Weifang, China

You may qualify if:

  • 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
  • \. 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.

You may not qualify if:

  • Participants who cannot communicate normally.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100191, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Pregnancy: During pregnancy and 42 days after delivery: the remaining peripheral blood sample (about 2ml) and urine sample (about 8ml); additional anticoagulant peripheral blood (5ml) and urine (10ml) of women and their husband (only when pregnant women were enrolled) . Pre-delivery: feces (5g). After delivery: samples of umbilical cord blood (about 10ml), placenta (8 to 10 pieces of tissue with a diameter of 1.0cm), umbilical cord (4 pieces of tissue with a length of 1cm), meconium (5g), and heel blood (about 0.5ml) Childhood: 6 months of age: extra fingertip blood (about 0.5ml). At the age of 1 and 2: urine sample (about 10ml) . At the age of 3 and 6: the remaining peripheral blood sample (about 2ml) and urine sample (about 8ml) . At the age of 9, 12, 15 and 17: the remaining peripheral blood sample examined by blood biochemistry (about 2ml) , the remaining peripheral blood sample examined by blood routine (about 2ml) and urine routine residual urine sample (about 8ml).

MeSH Terms

Conditions

Diabetes, GestationalHypertension, Pregnancy-InducedPremature BirthObesityAnemia

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHypertensionVascular DiseasesCardiovascular DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Haijun Wang, Ph.D

    Peking University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haijun Wang, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 23, 2024

First Posted

January 31, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2043

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations