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临床试验/NCT03814395
NCT03814395进行中(未招募)不适用

Peking University Birth Cohort in Tongzhou

Peking University1 个研究点 分布在 1 个国家目标入组 5,426 人开始时间: 2018年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
5,426
试验地点
1
主要终点
Numbers of participants with pregnancy complications

研究概览

简要总结

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.

详细描述

Maternal and child health is of great concern globally. Early life phase of a fetus and infant is a critical period for the development of health and disease in the whole life. Exposure of negative environmental, nutritional and lifestyle factors in pregnant women during this period can have adverse effects on fetal and infant. In addition, for mothers, complications during pregnancy could also have a negative effect on long-term health of mothers, such as diabetes, hypertension. Thus, the Peking University Birth Cohort in Tongzhou is primarily aimed 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.

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 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Numbers of participants with pregnancy complications

时间窗: At delivery

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

Numbers of participants with adverse pregnancy outcomes

时间窗: At delivery

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

次要结局

  • The proportion of children with warning signs(Age at 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)
  • Fetal Biparietal Diameter(At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.)
  • Fetal Head Circumference(At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.)
  • Fetal Femur Length(At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.)
  • Fetal Humerus Length(At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.)
  • Early Child development 1(Age at 6 weeks and 3 years)
  • Incidence of hypertension in women(6 weeks after delivery and 3 years after delivery)
  • 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)
  • Incidence of child overweight and obesity(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)
  • Fetal Abdominal Circumference(At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.)
  • 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 2(Age at 8-12 months)
  • Incidence of diabetes mellitus in women(6 weeks after delivery and 3 years after delivery)

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hai-Jun Wang

Prof.

Peking University

研究点 (1)

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