Clinical trial NCT02526901: The Born in Guangzhou Cohort Study (BIGCS)
Official title: The Born in Guangzhou Cohort Study (BIGCS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intrauterine Hyperglycemia
Pregnancy Outcomes
Neurodevelopment
Immune Development
Childhood Obesity
Host and Microbiome
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2015-08-18
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women attending their first routine antenatal examinations (usually around week 16) and their partners and offsrping

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Number of participant with pregnancy outcomes
timeFrame: At delivery
Secondary outcomes:
measure: Neurodevelopment during early childhood
timeFrame: At age of 3 years
measure: Weight changes during early childhood
timeFrame: At birth, age of 6 weeks, 6 months, 1 year and 3 years
measure: Height changes during early childhood
timeFrame: At birth, age of 6 weeks, 6 months, 1 year and 3 years
measure: Changes of body composition during early childhood
timeFrame: At birth, age of 6 weeks, 6 months, 1 year and 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center, China
name: Xiu Qiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.