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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02391610
Other study ID # 2008020
Secondary ID
Status Completed
Phase N/A
First received March 12, 2015
Last updated March 12, 2015
Start date November 2008
Est. completion date January 2015

Study information

Verified date March 2015
Source Anhui Medical University
Contact n/a
Is FDA regulated No
Health authority China: Anhui Medical University
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
No intervention


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fangbiao Tao

References & Publications (1)

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

Outcome

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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