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Clinical Trials/NCT02391610
NCT02391610
Completed
Not Applicable

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

Fangbiao Tao0 sites16,766 target enrollmentNovember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Environmental Exposures
Sponsor
Fangbiao Tao
Enrollment
16766
Primary Endpoint
Pregnancy outcomes and birth defects
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
January 2015
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Fangbiao Tao
Responsible Party
Sponsor Investigator
Principal Investigator

Fangbiao Tao

Professor and Dean

Anhui Medical University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Pregnancy outcomes and birth defects

Time Frame: 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

Secondary Outcomes

  • 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)

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