Effect of RIC on BP and Inflammatory Response in Women With Pre-eclampsia
Condition: Pre-Eclampsia; Mild; Gestational Hypertension
MeSH terms: Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      However, whether RIC actually can improve clinical outcomes in relation to lowering blood
      pressure and the inflammatory response in pregnant women with newly diagnosed hypertension is
      yet to be investigated.

      Aim and endpoint:

      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 (> 140/58mm Hg) or pre-eclampsia before
      gestational week 37+3.

      Primary end-point • Median arterial blood pressure after 6 days of treatment

      Secondary end-point

      • Changes in the inflammatory response

      Design and method:

      In a pilot cohort study at Aarhus University Hospital, Regional Hospital Randers and Region
      Hospital Herning 20 pregnant women with signs of gestational hypertension or pre-eclampsia
      (systolic blood pressure above 140 and / or diastolic blood pressure over 85; +/-
      proteinuria, +/- clinical signs or subjective symptoms and signs) are to be enrolled.

      The study flowchart:

      Newly hospital referred women with signs of gestational hypertension or pre-eclampsia will be
      asked to participate. Informed consent will be obtained and blood pressure, blood samples,
      and weight will be measured.

        -  Day 1: resting day at home - blood pressure measuring

        -  Day 2-7: Morning: Blood pressure measuring and RIC treatment. Evening: blood pressure
           measuring

        -  Day 7: In hospital: Blood samples and weight will be measured.

      Pros and cons:

      In relation to the inflation of the blood pressure cuff temporary moderate pains in the
      treated arm might occur. Otherwise, the RIC is without side effects. Two extra blood samples
      of app. 50 ml each will be drawn, with a small risk of local infection exist.

      The usefulness of the study The study is designed as a small pilot study. In which the set up
      will be tested and the effects on blood pressure and the inflammatory response in a relative
      small size will be explored. A larger randomised study will follow if the results show a
      positive trend.

      Positive as well as negative and inconclusive results will be widely disseminated through
      national and international scientific journals and conferences.
    

Intervention name(s): Remote Ischaemic Conditioning (RIC)
Intervention type(s): Device
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pre-Eclampsia; Mild; Pre-Eclampsia; Moderate; Gestational Hypertension; Remote ischemic conditioning