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

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:

  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 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

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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