NCT03561766

Brief Summary

The CMUBCS is a birth cohort study located in Shenyang, China. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Data are collected regarding environmental factors, family and lifestyle, clinical experimental outcomes and imaging results of pregnant women and children from birth to 18 years old. Biological samples including blood and tissue samples are also collected from the children and their parents.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
135mo left

Started Jun 2018

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 Progress42%
Jun 2018Jun 2037

First Submitted

Initial submission to the registry

May 21, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
17 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2037

Expected
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

May 21, 2018

Last Update Submit

December 9, 2019

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change of biometric parameter in centimeter of fetuses at the thirteenth week of gestational age

    Including head circumference, abdominal circumference, biparietal diameter, femur length of singleton and twin pregnancy

    At every week from the thirteenth week of gestational age to delivery of babies

  • Weight in kilogram of neonate

    Including singleton and twin pregnancy measured by nurses

    At birth of neonate

  • Gene expression of husbands of pregnancy women

    DNA methylation, histone acetylation etc. assessed by analyses of blood

    At 13 weeks of gestational age

  • Change of gene expression of pregnancy women

    DNA methylation, histone acetylation etc. assessed by analyses of blood

    At 13, 26 and 34 weeks of gestational age

  • Result of Non-invasive Prenatal Testing

    including singleton and twin pregnancy

    From 12 to 22 weeks of gestational age

Secondary Outcomes (4)

  • Change of intestinal flora during early childhood

    Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years

  • Height in centimeter changes during childhood

    Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years

  • Weight in kilogram changes during childhood

    Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years

  • Change of gene expression during childhood

    Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years

Eligibility Criteria

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

Pregnant women in Shenyang, China and their husband and children

You may qualify if:

  • Pregnant women, \<13 gestational weeks
  • Permanent residents or families intended to remain in Shenyang and surrounding areas
  • Pregnant women who are planned to be examined and delivered in Shengjing Hospital.

You may not qualify if:

  • Pregnant women who refuse to take part in the study
  • Pregnant women have diseases that might affect the results of researches, including neuropsychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

RECRUITING

Related Publications (1)

  • Zhang L, Du Y, Zhou J, Liu C, Li J, Qiao C. Timing of diagnostic workups in Chinese population with recurrent pregnancy loss: a cross-sectional study. BMC Pregnancy Childbirth. 2025 Mar 29;25(1):373. doi: 10.1186/s12884-025-07330-8.

Biospecimen

Retention: SAMPLES WITH DNA

During pregnancy: maternal blood, urine and stool ; fetal blood and oral mucosal cell At delivery: cord, cord blood and placenta During Infancy:dry blood spot During childhood: blood, buccal swab and stool

MeSH Terms

Conditions

Pregnancy ComplicationsOverweightObesity

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Caixia Liu

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the second obstetrical department

Study Record Dates

First Submitted

May 21, 2018

First Posted

June 19, 2018

Study Start

June 15, 2018

Primary Completion

June 1, 2020

Study Completion (Estimated)

June 1, 2037

Last Updated

December 12, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations