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临床试验/NCT03323762
NCT03323762已完成不适用

Effect of Remote Ischemic Conditioning on Blood Pressure and Inflammatory Response in Women With Pre-eclampsia and Gestational Hypertension

University of Aarhus6 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
6
主要终点
Median arterial blood pressure

研究概览

简要总结

The aim of this pilot cohort study is to investigate whether treatment with remote ischemic conditioning (RIC) has a beneficial effect on blood pressure as well as the immune system in pregnant women with newly diagnosed hypertension (> 140/58 mm Hg) or pre-eclampsia before gestational week 37+3.

详细描述

Pre-eclampsia, which affects about 2 to 7% of pregnancies, is a major cause of maternal and perinatal morbidity and mortality.

The onset of clinical symptoms (hypertension, proteinuria or end- organ dysfunction), are often seen in the last trimester of a pregnancy.

The disease can have major consequences for both the child and the mother. Yet there are only very limited treatment options, where induced labour is the only healing treatment. Today, the treatment consists in limiting blood pressure increase with medical treatment, whereby the pregnancy most often can result in term delivery.

Remote Ischaemic Conditioning (RIC) achieved by an automatic inflation of a blood pressure cuff to induce four 5-minute cycles of limb ischaemia and reperfusion, is a treatment that has been found to decrease the inflammatory response and lower blood pressure in states of myocardial infarction, chronic heart failure, and stroke.

The treatment is virtually a cost-free non-pharmacological and non-invasive therapeutic strategy performed by the patient herself in her home.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Systolic blood pressure above 140 and/or
  • Diastolic blood pressure above 85
  • Proteinuria +/-
  • Clinical signs / symptoms +/-
  • Clinical signs and symptoms of pre-eclampsia +/-

排除标准

  • Eclampsia

结局指标

主要结局

Median arterial blood pressure

时间窗: after 6 days of treatment

Median arterial blood pressure after 6 days of treatment

次要结局

  • The inflammatory response(after 6 days of treatment)
  • Medication(After 6 days of treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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