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临床试验/NCT03742011
NCT03742011招募中不适用

Health of Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study

Guangzhou Women and Children's Medical Center1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2012年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders)

时间窗: An average of 3 years old

Participants with one or more abnormal laboratory values will be considered as with glucolipid metabolism disorder.

次要结局

  • 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)

研究者

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiu Qiu

Director of the Born in Guangzhou Cohort Study

Guangzhou Women and Children's Medical Center

研究点 (1)

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