NCT02391610

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,766

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

1.9 years

First QC Date

March 12, 2015

Last Update Submit

March 12, 2015

Conditions

Keywords

birth cohort studyenvironmental exposuresbirth defectspregnant outcomeschildren development

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Children's physical development

    At ages of 1.5-3 and 4.5-6 years

  • Psychological and behavioural development

    At ages of 1.5-3 and 4.5-6 years

  • 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

Interventions

Eligibility Criteria

Age17 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Dean

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 18, 2015

Study Start

November 1, 2008

Primary Completion

October 1, 2010

Study Completion

January 1, 2015

Last Updated

March 18, 2015

Record last verified: 2015-03