Health of Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders)
Study Overview
Brief Summary
The Offspring Born to Mothers with Polycystic Ovary Syndrome in Guangzhou Cohort study (PCOS-BIG) was established to investigate the short- and long-term effects of intrauterine exposure to maternal PCOS on the health of offspring in Guangzhou, China. Data are collected regarding maternal PCOS subtypes, nursing, diet and education as well as health outcomes in their later life. Biological samples including blood and tissue samples are also collected from participants.
Detailed Description
According to preliminary survey, the prevalence of polycystic ovary syndrome (PCOS) among Chinese women reached 7.5%. Hyperandrogenism and insulin resistance were considered as the main pathogenesis of PCOS. As reported, the secretion of androgen is higher among women with PCOS than the healthy reference population throughout their fertile lives. Worth of concern, offspring of PCOS patients presented with glucolipid metabolism disorders as early as during their childhood, while whose pathogenesis remains unclear. Prenatal exposure of rhesus monkey in pregnant to androgens produces glucolipid metabolic alterations in offspring resembling those in PCOS, suggesting that the exposure of the fetus to hyperandrogenism during gestation could affect the glucolipid metabolism of PCOS offspring. Growing evidence shows that different exposures during pregnancy will affect the DNA methylation of offspring and disturb their endocrine and metabolism. A birth cohort would provide an opportunity to examine the short- and long-term effects of PCOS exposure, such as hyperandrogenism, on health consequences of the offspring.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Offspring born to women diagnosed with PCOS
- •Offspring born to women with <20 weeks of gestation, intended to eventually deliver in Guangzhou Women and Children's Medical Center
- •Permanent residents or families intended to remain in Guangzhou for ≥3 years
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders)
Time Frame: An average of 3 years old
Participants with one or more abnormal laboratory values will be considered as with glucolipid metabolism disorder.
Secondary Outcomes
- Change of intestinal flora(At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old)
- Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section(From the recruitment (≤ 20 weeks of gestation) to delivery)
- Neurodevelopment at early childhood(At age of 1 year old)
- Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect(At delivery)
- Epigenetic profiles of offspring(At birth)
- Weight changes(At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old)
- Height changes(At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old)
- Changes of the percentage of body fat(At age of 3 years,6 years, 12 years and 18 years old)
- Number of participants with reproductive endocrine disorders(At age of 12 years and 18 years old)
- Screen of intelligence quotient of offspring(At age of 6 years old)
- Intelligence quotient of offspring assessed by WPPSI-IV(At age of 6 years old)
- Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders)(At age of 6 years, 12 years and 18 years old)
Investigators
Xiu Qiu
Director of the Born in Guangzhou Cohort Study
Guangzhou Women and Children's Medical Center