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临床试验/NCT02990390
NCT02990390Unknown不适用

Shanghai First Maternity and Infant Hospital

Shanghai First Maternity and Infant Hospital1 个研究点 分布在 1 个国家目标入组 45,000 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
45,000
试验地点
1
主要终点
D-Dimer

研究概览

简要总结

RSA is a multifactorial disorder resulting from genetic factors, anatomic factors, autoimmune disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal infections. However, the underlying causes remain undetermined in up to 50% of cases. In this clinical cohort study, we intended to get an epidemiological evidence for patients with recurrent spontaneous abortion associated with thrombophilla.

研究设计

研究类型
Observational
观察模型
Cohort

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman who had 2 miscarriages before 12(th) week of gestation.Signed consent form.

排除标准

  • having experienced severe allergies, trauma history and/or operation history within 3 months;
  • with a history of mental illness and/or family history of mental illness
  • limb disabled
  • taking medicine within one month
  • suffering major events or having mood swings
  • with a history of recurrent pregnancy loss
  • having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
  • chromosome aberrations in anyone of the couple.

结局指标

主要结局

D-Dimer

时间窗: through study completion, an average of 3 year

次要结局

  • platelet aggregation time(through study completion, an average of 3 year)
  • BMI in kg/m^2(through study completion, an average of 3 year)
  • anticardiolipin antibody(through study completion, an average of 3 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shihua Bao

Principal Investigator

Shanghai First Maternity and Infant Hospital

研究点 (1)

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