Effect of Remote Ischemic Conditioning on Blood Pressure and Inflammatory Response in Women With Pre-eclampsia and Gestational Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 3
- 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
- 否
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
研究组 & 干预措施
RIC
RIC treatment arm The CellAegis auto RIC (automated blood pressure cuff) will be placed on the upper arm and inflated to 200 mmHg for 5 minutes followed by 5 minutes of deflation. The programmed cycle is repeated 4 times in total, summing up to a total treatment length of 35 minutes.
The treatment will be carried out on the morning of day 2 to day 7 by the participants themselves at their home.
干预措施: Remote Ischaemic Conditioning (RIC) (Device)
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)