Birth Defects Clinical Trial
Official title:
A Prospective Population-based Cohort Study That Recruited 16766 Pregnant Women From Six Major Cities of Anhui Province in China
Verified date | March 2015 |
Source | Anhui Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Anhui Medical University |
Study type | Observational |
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.
Status | Completed |
Enrollment | 16766 |
Est. completion date | January 2015 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 17 Years to 49 Years |
Eligibility |
Inclusion Criteria: 1. Having been lived in local city at least 6 months; 2. Establishing maternal card in the hospital for the first time; 3. Gestational week = 16 weeks; 4. Willing to have antenatal checkups and childbirth in the hospital where they establish maternal cards. Exclusion Criteria: 1. Women who have abnormities in speaking and can not complete the survey by themselves; 2. Women with mental disorders; 3. Women who plan to leave local places. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Fangbiao Tao |
Tao FB, Hao JH, Huang K, Su PY, Cheng DJ, Xing XY, Huang ZH, Zhang JL, Tong SL. Cohort Profile: the China-Anhui Birth Cohort Study. Int J Epidemiol. 2013 Jun;42(3):709-21. doi: 10.1093/ije/dys085. Epub 2012 Jun 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pregnancy outcomes and birth defects | 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 | Up to 12 months of age | No |
Secondary | Children's physical development | Including body height/length, body weight, blood pressure, blood lipoid | At ages of 1.5-3 and 4.5-6 years | No |
Secondary | Psychological and behavioural development | cognition, behaviour and temperament | At ages of 1.5-3 and 4.5-6 years | No |
Secondary | Family environmental exposure | Eating patterns and parenting style. | At ages of 1.5-3 and 4.5-6 years | No |
Secondary | Mental health problems | Mental retardation, attention deficit hyperactivity, disorder, autism spectrum disorders. | At ages of 1.5-3 & 4.5-6 years | No |
Secondary | Sexual development indicators | Secondary sexual characters, Sexual hormones. | At ages of 9-15 years for boys, and 8-14 years for girls | No |
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