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临床试验/NCT06234332
NCT06234332招募中不适用

Peking University Birth Cohort in Weifang

Peking University1 个研究点 分布在 1 个国家目标入组 2,800 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,800
试验地点
1
主要终点
Numbers and morbidity of participants with adverse pregnancy outcomes

研究概览

简要总结

The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, 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 before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.

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 Weifang 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, husbands and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces samples are also collected.

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
All
接受健康志愿者

入选标准

  • Pregnant woman
  • Pregnant women, 6-13^+6 gestational weeks
  • Resided in Weifang 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 Weifang maternal&Child Hospital.
  • Pregnant women who is willing to participate in this study with informed consent
  • Pregnant woman's husband
  • His wife was eligible for enrollment
  • He is the biological father of the child (his wife's current pregnancy)
  • Pregnant women's husband who is willing to participate in this study with informed consent
  • Offspring
  • Children born to pregnant women who met the inclusion criteria after enrolling in this study.
  • 5. Before the age of 8 years, his/her mother provided written informed consent.
  • After 8 years old, he/she agreed to continue this study and signed the informed consent.

排除标准

  • Participants who cannot communicate normally.

结局指标

主要结局

Numbers and morbidity of participants with adverse pregnancy outcomes

时间窗: At delivery

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

Numbers and morbidity of participants with pregnancy complications

时间窗: At delivery

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

次要结局

  • Incidence of attention-deficit/hyperactivity disorder in children(Age at 6 years)
  • Incidence of diabetes mellitus in women(6 weeks after delivery and 3 years after delivery)
  • Weight in kilogram changes during childhood(At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years)
  • Incidence of autism spectrum disorder in children(Age at 2 years, 3 years)
  • Incidence of anxiety in adolescents(Age at 9 years, 12 years, 15 years, and 17 years)
  • Height in centimeter changes during childhood(At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years)
  • Early Child development(Age at 6 weeks, 6 months and 12 months)
  • Incidence of hypertension in women(6 weeks after delivery and 3 years after delivery)
  • Incidence of child overweight and obesity(At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years)
  • Incidence of depression in adolescents(Age at 9 years, 12 years, 15 years, and 17 years)

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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