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Effect of RIC on BP and Inflammatory Response in Women With Pre-eclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03323762
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : January 6, 2021
Sponsor:
Collaborators:
Randers Regional Hospital
Herning Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia; Mild Gestational Hypertension Device: Remote Ischaemic Conditioning (RIC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischemic Conditioning on Blood Pressure and Inflammatory Response in Women With Pre-eclampsia and Gestational Hypertension
Actual Study Start Date : October 24, 2017
Actual Primary Completion Date : August 28, 2020
Actual Study Completion Date : August 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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




Primary Outcome Measures :
  1. Median arterial blood pressure [ Time Frame: after 6 days of treatment ]
    Median arterial blood pressure after 6 days of treatment


Secondary Outcome Measures :
  1. The inflammatory response [ Time Frame: after 6 days of treatment ]
    Changes in the inflammatory response after 6 days of treatment

  2. Medication [ Time Frame: After 6 days of treatment ]
    prescription of antihypertensive



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Obs pre-eclampsia
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323762


Locations
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Denmark
Aarhus University hospital
Aarhus, Denmark, 8200
Herning Hospital
Herning, Denmark, 7400
Randers Hospital
Randers, Denmark, 8930
Sponsors and Collaborators
University of Aarhus
Randers Regional Hospital
Herning Hospital
Investigators
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Principal Investigator: Ulla Kristine Møller Liendgaard, Phd, MHSc. Aarhus University Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03323762    
Other Study ID Numbers: RIC & pre-eclampsia
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Pre-Eclampsia; Mild
Pre-Eclampsia; Moderate
Gestational Hypertension
Remote ischemic conditioning
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications