- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02391610
The China-Anhui Birth Cohort Study (C-ABCS)
March 12, 2015 updated by: Fangbiao Tao
A Prospective Population-based Cohort Study That Recruited 16766 Pregnant Women From Six Major Cities of Anhui Province in China
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
16766
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 49 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The China-Anhui Birth Cohort Study (C-ABCS) is a prospective population-based cohort study that recruited 16766 pregnant women from six major cities of Anhui province in China between November 2008 and October 2010.
Six cities were selected for study sites, including Hefei, Ma'anshan, Wuhu, Jieshou, Lu'an and Ningguo.
Anhui province is located in the south-east of China.
Its socio-economic development is ranked at the mid-level in China.
Six cities were selected according to their social and geographic characteristics.
These cities are located in Central, Southern and Northern regions of Anhui Province and may represent socio-economic, geographic and cultural variations.
In addition, strong local support was one of the important factors to consider in selecting these cities.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 12 months of age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's physical development
Time Frame: At ages of 1.5-3 and 4.5-6 years
|
Including body height/length, body weight, blood pressure, blood lipoid
|
At ages of 1.5-3 and 4.5-6 years
|
Psychological and behavioural development
Time Frame: At ages of 1.5-3 and 4.5-6 years
|
cognition, behaviour and temperament
|
At ages of 1.5-3 and 4.5-6 years
|
Family environmental exposure
Time Frame: At ages of 1.5-3 and 4.5-6 years
|
Eating patterns and parenting style.
|
At ages of 1.5-3 and 4.5-6 years
|
Mental health problems
Time Frame: At ages of 1.5-3 & 4.5-6 years
|
Mental retardation, attention deficit hyperactivity, disorder, autism spectrum disorders.
|
At ages of 1.5-3 & 4.5-6 years
|
Sexual development indicators
Time Frame: At ages of 9-15 years for boys, and 8-14 years for girls
|
Secondary sexual characters, Sexual hormones.
|
At ages of 9-15 years for boys, and 8-14 years for girls
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
March 12, 2015
First Submitted That Met QC Criteria
March 12, 2015
First Posted (Estimate)
March 18, 2015
Study Record Updates
Last Update Posted (Estimate)
March 18, 2015
Last Update Submitted That Met QC Criteria
March 12, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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