Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
hydroxychloroquine group
hydroxychloroquine 400 mg preconceptional
干预措施: Hydroxychloroquine (Drug)
hydroxychloroquine group
hydroxychloroquine 400 mg preconceptional
干预措施: Folic Acid (Drug)
hydroxychloroquine group
hydroxychloroquine 400 mg preconceptional
干预措施: Low-dose aspirin (Drug)
control group
not receive hydroxychloroquine
干预措施: Folic Acid (Drug)
control group
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
Abdelrahman Mahmoud Mohammed
Assistant Lecturer
Assiut University
