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Recruiting NCT03561766

Birth Cohort Study of China Medical University

Observational Twin; Complicating Pregnancy Advanced Maternal Age Pregnancy Scarred Uterus Overweight and Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Twin; Complicating Pregnancy, Advanced Maternal Age Pregnancy, Scarred Uterus, Overweight and Obesity. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Birth Cohort Study of China Medical University in Shenyang

Overview

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.

Detailed description

Early life phase (fetal and infant) is a critical period for the development of health and disease in a person's life. Many adult chronic diseases, such as diabetes, cardiovascular and cerebrovascular diseases, all come from the exposure of negative environmental and behavioral factors during this period. By collecting the lifestyle data and clinical data of pregnant women at different periods, the appropriate indicators are anticipated to be selected to predict and evaluate the outcome of pregnancy and the health of the mothers and children in the long term. The status of overweight and obesity of children in Shenyang and its surrounding areas are anticipated to be analyzed by descriptive and etiological analysis through collecting the lifestyle data and clinical data of different periods of pregnant women and the lifestyle data of different developmental stages of children.

Primary outcome measures

  • Change of biometric parameter in centimeter of fetuses at the thirteenth week of gestational age [Time frame: At every week from the thirteenth week of gestational age to delivery of babies]
  • Weight in kilogram of neonate [Time frame: At birth of neonate]
  • Gene expression of husbands of pregnancy women [Time frame: At 13 weeks of gestational age]
  • Change of gene expression of pregnancy women [Time frame: At 13, 26 and 34 weeks of gestational age]
  • Result of Non-invasive Prenatal Testing [Time frame: From 12 to 22 weeks of gestational age]
Secondary outcome measures (4)
  • Change of intestinal flora during early childhood [Time frame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years]
  • Height in centimeter changes during childhood [Time frame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years]
  • Weight in kilogram changes during childhood [Time frame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years]
  • Change of gene expression during childhood [Time frame: Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shengjing Hospital — Shenyang

Publications

  • 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. PMID 40158174

Identifiers

NCT: NCT03561766 · CMUBCS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗