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Trial record 12 of 118 for:    Recruiting, Not yet recruiting, Available Studies | "Hypertension, Pregnancy-Induced"

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

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ClinicalTrials.gov Identifier: NCT03323762
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : May 3, 2018
Sponsor:
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 first-line pregnant women with newly diagnosed hypertension (> 140/90 mm Hg) or pre-eclampsia before gestational week 37.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischaemic Conditioning on Blood Pressure and Inflammatory Response in Women With Pre-clampsia and Gestational Hypertention
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

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 antihypertensiva



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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 90
  • 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


Contacts
Contact: Ulla Kristine Møller Liendgaard, Phd, MHSc. +45 28748771 k.moller@clin.au.dk
Contact: Niels Uldbjerg, Prof. DMSc +4578453325 uldbjerg@clin.au.dk

Locations
Denmark
Aarhus University hospital Recruiting
Aarhus, Denmark, 8200
Contact: Kristine Liendgaard, Phd, MHSc    +4528748771    K.moller@clin.au.dk   
Contact: Niels Uldbjerg, Prof, DMSc    +4578453325    uldbjerg@clin.au.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Ulla Kristine Møller Liendgaard, Phd, MHSc. Aarhus University Hospital

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03323762     History of Changes
Other Study ID Numbers: RIC & pre-eclampsia
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Hypertension
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications