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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03323762
Other study ID # RIC & pre-eclampsia
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 24, 2017
Est. completion date August 28, 2020

Study information

Verified date January 2019
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date August 28, 2020
Est. primary completion date August 28, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Systolic blood pressure above 140 and/or - Diastolic blood pressure above 85 - Proteinuria +/- - Clinical signs / symptoms +/- Clinical signs and symptoms of pre-eclampsia +/- Exclusion Criteria: • Eclampsia

Study Design


Intervention

Device:
Remote Ischaemic Conditioning (RIC)
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

Locations

Country Name City State
Denmark Aarhus University hospital Aarhus
Denmark Herning Hospital Herning
Denmark Randers Hospital Randers

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus Herning Hospital, Randers Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Median arterial blood pressure Median arterial blood pressure after 6 days of treatment after 6 days of treatment
Secondary The inflammatory response Changes in the inflammatory response after 6 days of treatment after 6 days of treatment
Secondary Medication prescription of antihypertensive After 6 days of treatment
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