跳至主要内容
临床试验/NCT02391610
NCT02391610已完成不适用

A Prospective Population-based Cohort Study That Recruited 16766 Pregnant Women From Six Major Cities of Anhui Province in China

Fangbiao Tao0 个研究点目标入组 16,766 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16,766
主要终点
Pregnancy outcomes and birth defects

研究概览

简要总结

The China-Anhui Birth Cohort Study (C-ABCS) was set up to examine the delayed, cumulative and interactive effects of maternal environmental exposures on birth outcomes and children's development. The C-ABCS recruited pregnant women from six major cities of Anhui province, China, between November 2008 and October 2010. A range of data (including demographic, obstetric, occupational, nutritional and psychosocial factors) were collected by both interviews and laboratory tests. In each trimester, women's blood samples were drawn, and pregnancy complications were abstracted from physician's medical records. By the end of 2011, birth outcomes/birth defects were observed/identified by clinicians within 12 months after the delivery of 11 421 singleton live births of six cities and those outcomes among the remaining 2033 live births are still being observed. In addition, 4668 children from Ma'anshan city will be further followed up during the pre-school period till they reach adolescence to obtain the data on familial environmental exposures as well as children's physical, psychological, behavioural and sexual development. The interview data and information on laboratory examinations are available on request from archives in the Anhui Provincial Key Laboratory of Population Health & Aristogenics.

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
17 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Having been lived in local city at least 6 months;
  • Establishing maternal card in the hospital for the first time;
  • Gestational week ≤ 16 weeks;
  • Willing to have antenatal checkups and childbirth in the hospital where they establish maternal cards.

排除标准

  • Women who have abnormities in speaking and can not complete the survey by themselves;
  • Women with mental disorders;
  • Women who plan to leave local places.

结局指标

主要结局

Pregnancy outcomes and birth defects

时间窗: Up to 12 months of age

By clinical diagnosis, including abortion/premature birth/prolonged pregnancy/fetal death/stillbirth/live birth, Low birthweight/macrosomia/small for gestation age/large for gestation age, Structural birth defects and functional birth defects

次要结局

  • Family environmental exposure(At ages of 1.5-3 and 4.5-6 years)
  • Mental health problems(At ages of 1.5-3 & 4.5-6 years)
  • Sexual development indicators(At ages of 9-15 years for boys, and 8-14 years for girls)
  • Psychological and behavioural development(At ages of 1.5-3 and 4.5-6 years)
  • Children's physical development(At ages of 1.5-3 and 4.5-6 years)

研究者

发起方
Fangbiao Tao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fangbiao Tao

Professor and Dean

Anhui Medical University

相似试验