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NCT Number: NCT03561766

Birth Cohort Study of China Medical University

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.

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Key information

Conditions

Twin; Complicating Pregnancy Advanced Maternal Age Pregnancy Body Weight Female Urogenital Diseases and Pregnancy Complications Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Pregnancy Complications Scarred Uterus Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. 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

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

  2. Weight in kilogram of neonate

    Time frame: At birth of neonate

    Including singleton and twin pregnancy measured by nurses

  3. Gene expression of husbands of pregnancy women

    Time frame: At 13 weeks of gestational age

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

  4. Change of gene expression of pregnancy women

    Time frame: At 13, 26 and 34 weeks of gestational age

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

  5. Result of Non-invasive Prenatal Testing

    Time frame: From 12 to 22 weeks of gestational age

    including singleton and twin pregnancy

Secondary outcomes

  1. 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

    Assessed by analyses of stool samples

  2. 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

    Measured by nurses in clinic

  3. 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

    Measured by nurses in clinic

  4. 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

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

Study contacts

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

Caixia Liu

CONTACT

[email protected]

86-18902451716

Shaojiang Liu

CONTACT

[email protected]

86-18002454803

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

Birth Cohort Study of China Medical University in Shenyang

Important dates

Study start
2018
Primary completion
2020
Study completion
2037
First posted
Jun 19, 2018
Registry last updated
Dec 12, 2019

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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