跳至主要内容
临床试验/NCT03561766
NCT03561766招募中不适用

Birth Cohort Study of China Medical University in Shenyang

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Change of biometric parameter in centimeter of fetuses at the thirteenth week of gestational age

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: 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

Weight in kilogram of neonate

时间窗: At birth of neonate

Including singleton and twin pregnancy measured by nurses

Gene expression of husbands of pregnancy women

时间窗: At 13 weeks of gestational age

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

Result of Non-invasive Prenatal Testing

时间窗: From 12 to 22 weeks of gestational age

including singleton and twin pregnancy

Change of gene expression of pregnancy women

时间窗: At 13, 26 and 34 weeks of gestational age

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

次要结局

  • Change of intestinal flora during early 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)
  • Height in centimeter 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caixia Liu

Director of the second obstetrical department

Shengjing Hospital

研究点 (1)

Loading locations...

相似试验