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.
