Intrauterine HyperglycemiaBIGCSNCT02526901
The Born in Guangzhou Cohort Study (BIGCS)
An observational study of Intrauterine Hyperglycemia and Pregnancy Outcomes, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial summary
The Born in Guangzhou Cohort Study (BIGCS) was established to investigate the short- and long-term effects of exposure in early life on health consequences in Guangzhou, China. Data are collected regarding environmental, occupational and lifestyle exposures as well as health outcomes in later life. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Hyperglycemia, Pregnancy Outcomes, Neurodevelopment
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2012to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women attending their first routine antenatal examinations (usually around week 16) and their partners and offsrping
Who may be able to join
- Pregnant women with <20 weeks of gestation
- Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center
- Permanent residents or families intended to remain in Guangzhou with their child for ≥3 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
Xiu Qiu, PhD, 0086 20 38367160, qxiu0161@163.com
Jianrong He, MS, 0086 20 38367160, hjr0703@163.com
About this study
The Born in Guangzhou Cohort Study (BIGCS) was established to investigate the short- and long-term effects of exposure in early life on health consequences in Guangzhou, China. Data are collected regarding environmental, occupational and lifestyle exposures as well as health outcomes in later life. Biological samples including blood and tissue samples are also collected from the participants.
Read the detailed description
Over the past three decades, China is undergoing rapidly economic development. At the same time, the Western diet and urban lifestyle has been more common than before, which may lead to an increase of incidence of non-communicable chronic diseases, such as diabetes and malignancies. Notably, the current generation of Chinese adults, particularly those in their middle age or older, were born in an era where hardship and rationing was the norm and witnessed a social and epidemiological transition that might have a profound effect on their present health. In contrast, the younger generation is raised in relative material abundance, under the influence of traditional Chinese values such as a strong family orientation and an emphasis on academic success. A birth cohort with would provide an opportunity to examine the short- and long-term effects of exposure in early life on health consequences in this younger generation, in the context of rapid development in China.
- Conditions
- Intrauterine Hyperglycemia, Pregnancy Outcomes, Neurodevelopment, Immune Development, Childhood Obesity, Host and Microbiome
- Being tested
- No intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participant with pregnancy outcomes
Including abortion, stillbirth, live birth, preterm birth, low birth weight and birth defects
Measured: At delivery
Secondary outcomes (4)
Neurodevelopment during early childhood
Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules and Ages and Stages Questionnaire
Measured: At age of 3 years
Weight changes during early childhood
Weight changes from birth, 6 weeks, 6 months, 1 year to 3 years
Measured: At birth, age of 6 weeks, 6 months, 1 year and 3 years
Height changes during early childhood
Height changes from birth, 6 weeks, 6 months, 1 year to 3 years
Measured: At birth, age of 6 weeks, 6 months, 1 year and 3 years
Changes of body composition during early childhood
Changes of body composition from birth, 6 weeks, 6 months, 1 year to 3 years. Body composition is assessed using Dual Energy X-Ray Absorptiometry
Measured: At birth, age of 6 weeks, 6 months, 1 year and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start1 Feb 2012
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
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 Intrauterine HyperglycemiaStudies 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
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Principal investigator, Xiu Qiu, Guangzhou Women and Children's Medical Center
- Investigators
- Xiu Qiu, PhD, Principal investigator, Guangzhou Women and Children's Medical Center, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526901
- Sponsor's protocol ID
- 2011Y2-00025
- Other IDs
- 201041-E00741, 2012J5100038, 201508030037
- Acronym
- BIGCS
- Status last verified
- Feb 2024
- First submitted
- 13 Aug 2015
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
He JR, Yuan MY, Chen NN, Lu JH, Hu CY, Mai WB, Zhang RF, Pan YH, Qiu L, Wu YF, Xiao WQ, Liu Y, Xia HM, Qiu X. Maternal dietary patterns and gestational diabetes mellitus: a large prospective cohort study in China. Br J Nutr. 2015 Apr 28;113(8):1292-300. doi: 10.1017/S0007114515000707. Epub 2015 Mar 30.
PubMed 25821944
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Born in Guangzhou Cohort Study (BIGCS)
- ClinicalTrials.gov ID
- NCT02526901
- Acronym / sponsor ID
- BIGCS / 2011Y2-00025
- Conditions
- Intrauterine Hyperglycemia, Pregnancy Outcomes, Neurodevelopment, Immune Development, Childhood Obesity, Host and Microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 1 Feb 2012
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Aug 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 Born in Guangzhou Cohort Study (BIGCS) was established to investigate the short- and long-term effects of exposure in early life on health consequences in Guangzhou, China. Data are collected regarding environmental, occupational and lifestyle exposures as well as health outcomes in later life. Biological samples including blood and tissue samples are also collected from the participants.
Detailed description
Over the past three decades, China is undergoing rapidly economic development. At the same time, the Western diet and urban lifestyle has been more common than before, which may lead to an increase of incidence of non-communicable chronic diseases, such as diabetes and malignancies. Notably, the current generation of Chinese adults, particularly those in their middle age or older, were born in an era where hardship and rationing was the norm and witnessed a social and epidemiological transition that might have a profound effect on their present health. In contrast, the younger generation is raised in relative material abundance, under the influence of traditional Chinese values such as a strong family orientation and an emphasis on academic success. A birth cohort with would provide an opportunity to examine the short- and long-term effects of exposure in early life on health consequences in this younger generation, in the context of rapid development in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women attending their first routine antenatal examinations (usually around week 16) and their partners and offsrping
Key inclusion criteria (3 listed)
- Pregnant women with <20 weeks of gestation
- Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center
- Permanent residents or families intended to remain in Guangzhou with their child for ≥3 years
Key exclusion criteria (0 listed)
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 | No treatment |
Primary outcome
Number of participant with pregnancy outcomes
Time frame: At delivery
Including abortion, stillbirth, live birth, preterm birth, low birth weight and birth defects
4 secondary outcomes
Neurodevelopment during early childhood
Time frame: At age of 3 years
Weight changes during early childhood
Time frame: At birth, age of 6 weeks, 6 months, 1 year and 3 years
Height changes during early childhood
Time frame: At birth, age of 6 weeks, 6 months, 1 year and 3 years
Changes of body composition during early childhood
Time frame: At birth, age of 6 weeks, 6 months, 1 year and 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 25821944He JR, Yuan MY, Chen NN, Lu JH, Hu CY, Mai WB, Zhang RF, Pan YH, Qiu L, Wu YF, Xiao WQ, Liu Y, Xia HM, Qiu X. Maternal dietary patterns and gestational diabetes mellitus: a large prospective cohort study in China. Br J Nutr. 2015 Apr 28;113(8):1292-300. doi: 10.1017/S0007114515000707. Epub 2015 Mar 30.
- BIGCS websiteLink provided by the sponsor.
Related trials for Intrauterine Hyperglycemia
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Westlake Precision Birth Cohort
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Wenzhou Gestational Diabetes Cohort
Gestational Diabetes Mellitus, Intrauterine Hyperglycemia
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.
Xiu Qiu, PhD principal investigator
Guangzhou Women and Children's Medical Center, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Hyperglycemia and Pregnancy Outcomes, run by Guangzhou Women and Children's Medical Center at 1 site in China.
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 3 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiu Qiu, PhD (0086 20 38367160, qxiu0161@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participant with pregnancy outcomes (time frame: At delivery). 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 NCT02526901, 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 26 Feb 2024; AzTrials last refreshed its copy on 26 Oct 2026.