NCT03814395

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

June 28, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2019

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

January 16, 2019

Last Update Submit

November 15, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Numbers of participants with pregnancy complications

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

    At delivery

  • Numbers of participants with adverse pregnancy outcomes

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

    At delivery

Secondary Outcomes (13)

  • 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

  • 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

  • Early Child development 1

    Age at 6 weeks and 3 years

  • Early Child development 2

    Age at 8-12 months

  • Incidence of diabetes mellitus in women

    6 weeks after delivery and 3 years after delivery

  • +8 more secondary outcomes

Study Arms (2)

Exposure group

Group with environmental, nutritional or lifestyle exposures

Other: No intervention

Non-exposed group

Group without any environmental, nutritional and lifestyle exposures

Interventions

This is an observational study without any intervention

Exposure group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women and their children in Tongzhou, China

You may qualify if:

  • Pregnant women, \<14 gestational weeks
  • Resided in Tongzhou 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 Tongzhou maternal\&Child Hospital.
  • Pregnant women who is willing to participate in this study with informed consent

You may not qualify if:

  • Pregnant women have chronic disease before pregnancy, including diabetes,hypertension, liver disease and kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (1)

  • Jin C, Lin L, Han N, Zhao Z, Liu Z, Luo S, Xu X, Liu J, Wang H. Effects of dynamic change in fetuin-A levels from the first to the second trimester on insulin resistance and gestational diabetes mellitus: a nested case-control study. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e000802. doi: 10.1136/bmjdrc-2019-000802.

Biospecimen

Retention: SAMPLES WITH DNA

During pregnancy: maternal blood. At delivery: cord blood,umbilical cord and placenta. During childhood: blood.

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

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 16, 2019

First Posted

January 24, 2019

Study Start

June 28, 2018

Primary Completion

August 27, 2019

Study Completion

August 28, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations