An interventional study of Remote Ischaemic Conditioning (RIC) in Pre-Eclampsia; Mild and Gestational Hypertension, sponsored by University of Aarhus. Completed at 3 sites in Denmark. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-01-06.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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Among 20 studies in Pre-Eclampsia with a site in Denmark — 6 open to participants now, 7 under way, 1 of them phase 3. Pre-Eclampsia · Denmark.
Among the 20 studies in Pre-Eclampsia with a site in Denmark, this one is the only one that started in 2017, is one of 4 with no phase, and was the 9th registered.
917 studies on the registry are indexed under Pre-Eclampsia; 244 are open to participants now.
Browse Pre-Eclampsia studies →6 of the 20 studies in Pre-Eclampsia with a site in Denmark are open now. Recruiting first, the newest first:
University of Calgary · Sites in Denmark, Belgium, Canada and 4 more countries
Ages 18+ · Women only
Copenhagen University Hospital at Herlev · Sites in Denmark
Women only · Healthy volunteers
Herlev Hospital · Sites in Denmark
Ages 18+ · Women only · Healthy volunteers
Copenhagen University Hospital, Hvidovre · Sites in Denmark
Ages 18+ · Women only
University Hospital Bispebjerg and Frederiksberg · Sites in Denmark
Ages 16–48 · Women only · Healthy volunteers
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 110 across 481 interventional studies indexed under Pre-Eclampsia.
Median enrollment 600 across the 5 interventional studies, 513 across the 15 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 20 has an industry lead sponsor. The 10 most frequent:
University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
University of Aarhus has 4 studies filed under Pre-Eclampsia — fewer than ten, so there is no comparison to draw.
4 of the studies in Pre-Eclampsia with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06844019Herlev HospitalBirth & Breastfeeding Support Study | 2027-01-06 |
| NCT06471140Aalborg University HospitalMaternal Cardiovascular Adaption to Pregnancy in IVF Patients Following Frozen Embryo Transfer (FET) | 2027-08-01 |
| NCT07263490Copenhagen University Hospital, HvidovrePRIOR Study (Pre-eclampsia Risk In Oocyte Recipients) | 2027-10-31 |
| NCT07485140Copenhagen University Hospital at HerlevPrevention of Preeclampsia in Denmark: A National Implementation Study | 2027-11 |
Add all 4 to your calendar (.ics) → With an account.
Among the 20 studies in Pre-Eclampsia with a site in Denmark, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical signs and symptoms of pre-eclampsia +/-
Exclusion Criteria:
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.
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
Median arterial blood pressure
Median arterial blood pressure after 6 days of treatment
Time frame: after 6 days of treatment
The inflammatory response
Changes in the inflammatory response after 6 days of treatment
Time frame: after 6 days of treatment
Medication
prescription of antihypertensive
Time frame: After 6 days of treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Aug 2020, 34 months.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's 34 months is above that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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