Environmental ExposuresNCT02391610
The China-Anhui Birth Cohort Study (C-ABCS)
An observational study of Environmental Exposures and Other Pregnancy With Abortive Outcome, run by Fangbiao Tao.
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. Read more about this study
- Who is it for?
- Ages 17 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposures, Other Pregnancy With Abortive Outcome, Birth Defects
- How many people
- 16,766 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Environmental Exposures, Other Pregnancy With Abortive Outcome, Birth Defects, Children Development
- Being tested
- No intervention
- Keywords
- birth cohort study, environmental exposures, birth defects, pregnant outcomes, children development
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 months of age
Secondary outcomes (5)
Children's physical development
Including body height/length, body weight, blood pressure, blood lipoid
Measured: At ages of 1.5-3 and 4.5-6 years
Psychological and behavioural development
cognition, behaviour and temperament
Measured: At ages of 1.5-3 and 4.5-6 years
Family environmental exposure
Eating patterns and parenting style.
Measured: At ages of 1.5-3 and 4.5-6 years
Mental health problems
Mental retardation, attention deficit hyperactivity, disorder, autism spectrum disorders.
Measured: At ages of 1.5-3 & 4.5-6 years
Sexual development indicators
Secondary sexual characters, Sexual hormones.
Measured: At ages of 9-15 years for boys, and 8-14 years for girls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startNov 2008
- Primary completionOct 2010
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Environmental ExposuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,766 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fangbiao Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fangbiao Tao, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391610
- Sponsor's protocol ID
- 2008020
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22729236
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Population-based Cohort Study That Recruited 16766 Pregnant Women From Six Major Cities of Anhui Province in China
- ClinicalTrials.gov ID
- NCT02391610
- Acronym / sponsor ID
- 2008020
- Conditions
- Environmental Exposures, Other Pregnancy With Abortive Outcome, Birth Defects, Children Development
- Keywords
- birth cohort study, environmental exposures, birth defects, pregnant outcomes, children development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,766 participants (actual)
- Lead sponsor
- Fangbiao TaoUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | – |
Primary outcome
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
5 secondary outcomes
Children's physical development
Time frame: 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
Family environmental exposure
Time frame: 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
Sexual development indicators
Time frame: At ages of 9-15 years for boys, and 8-14 years for girls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Results publication: PubMed 22729236Tao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Environmental Exposures and Other Pregnancy With Abortive Outcome, run by Fangbiao Tao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy outcomes and birth defects (time frame: Up to 12 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02391610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015; AzTrials last refreshed its copy on 31 Oct 2026.