The China-Anhui Birth Cohort Study (C-ABCS)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391610
• Other study ID #: 2008020
• 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

• Abortion, Spontaneous
• Birth Defects
• Children Development
• Congenital Abnormalities
• Environmental Exposures
• Other Pregnancy With Abortive Outcome

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