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临床试验/NCT04755322
NCT04755322已完成不适用

Hydroxychloroquine is an Immunomodulator for Improvement of Pregnancy Outcomes in Preeclampsia

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年3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
50
试验地点
1
主要终点
number of cases of preeclampsia

研究概览

简要总结

Pre-eclampsia complicates up to 8% of pregnancies and is a major contributor to maternal mortality and morbidity The only effective treatment is delivery, which leads to significant neonatal morbidity and mortality if carried out preterm, especially when the disease occurs early in pregnancy. Vascular endothelial dysfunction and immunological impairment are associated with preeclampsia. To date, there is no effective or optimal therapeutic approach for these conditions. 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

  • Pregnant women in 1st 6 weeks gestation.
  • History of preeclampsia in previous pregnancies.
  • Women who accepted to participate

排除标准

  • Risk factors (multiple gestation, chronic hypertension, chronic renal disease).
  • Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, chronic liver or kidney insufficiency, heart block, significant chronic digestive, hematologic disease epilepsy or psychotic disorders.) or disorder of lactose metabolism
  • Patient already using HCQ (rheumatoid arthritis, Lupus, solar eczema). 4.impossible for follow up

研究组 & 干预措施

hydroxychloroquine group

Other

hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg

干预措施: Folic acid (Drug)

hydroxychloroquine group

Other

hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg

干预措施: Hydroxychloroquine (Drug)

hydroxychloroquine group

Other

hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg

干预措施: Low-dose aspirin (Drug)

control group

Other

Folic Acid 5 mg+ Low-dose aspirin 75 mg

干预措施: Folic acid (Drug)

control group

Other

Folic Acid 5 mg+ Low-dose aspirin 75 mg

干预措施: Low-dose aspirin (Drug)

结局指标

主要结局

number of cases of preeclampsia

时间窗: 9 month

次要结局

  • number of cases of Number of pregnancy complications such as FGR, IUFD, and gestational hypertension, HELLP syndrome, placental abruption, eclampsia, ICU admission and pulmonary edema(9 month)
  • Number of pregnancies with fetal malformation(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

Assisstant lecturer

Assiut University

研究点 (1)

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