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临床试验/NCT04228263
NCT04228263已完成不适用

Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage

Assiut University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
1
主要终点
Number of viable fetuses at 20 weeks gestation

研究概览

简要总结

Recurrent miscarriage affects women of childbearing age worldwide. Vascular endothelial dysfunction and immunological impairment are associated with recurrent miscarriage To date, there is no effective or optimal therapeutic approach for these condition. Hydroxychloroquine has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or direct endothelial protection. Hydroxychloroquine is an antimalarial and immunomodulatory agent. In pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve placental function in pregnancies associated with heightened inflammation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

hydroxychloroquine group

Other

hydroxychloroquine 400 mg preconceptional

干预措施: Hydroxychloroquine (Drug)

hydroxychloroquine group

Other

hydroxychloroquine 400 mg preconceptional

干预措施: Folic Acid (Drug)

hydroxychloroquine group

Other

hydroxychloroquine 400 mg preconceptional

干预措施: Low-dose aspirin (Drug)

control group

Other

not receive hydroxychloroquine

干预措施: Folic Acid (Drug)

control group

Other

not receive hydroxychloroquine

干预措施: Low-dose aspirin (Drug)

结局指标

主要结局

Number of viable fetuses at 20 weeks gestation

时间窗: 5 months

次要结局

  • Number of Preterm delivery before 37 week gestation.(8 months)
  • Number of patients with miscarriage before 20 weeks(5 months)
  • Number of pregnancy complications such as ( FGR or preeclampsia, IUFD after 20 week gestation)(9 months)
  • Number of fetus with Major congenital anmalies(9 months)
  • Number of Live birth(9 months)

研究者

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

Abdelrahman Mahmoud Mohammed

Assistant Lecturer

Assiut University

研究点 (1)

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