NCT03323762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2020

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

October 24, 2017

Last Update Submit

January 4, 2021

Conditions

Pre-Eclampsia; MildGestational Hypertension

Keywords

Pre-Eclampsia; MildPre-Eclampsia; ModerateGestational HypertensionRemote ischemic conditioning

Outcome Measures

Primary Outcomes (1)

  • Median arterial blood pressure

    Median arterial blood pressure after 6 days of treatment

    after 6 days of treatment

Secondary Outcomes (2)

  • The inflammatory response

    after 6 days of treatment

  • Medication

    After 6 days of treatment

Study Arms (1)

RIC

EXPERIMENTAL

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)

Interventions

Remote Ischaemic Conditioning (RIC)DEVICE

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

RIC

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsObs pre-eclampsia
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Systolic blood pressure above 140 and/or
  • Diastolic blood pressure above 85
  • Proteinuria +/-
  • Clinical signs / symptoms +/-
  • Clinical signs and symptoms of pre-eclampsia +/-

You may not qualify if:

  • Eclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University hospital

Aarhus, 8200, Denmark

Location

Herning Hospital

Herning, 7400, Denmark

Location

Randers Hospital

Randers, 8930, Denmark

Location

MeSH Terms

Conditions

Pre-EclampsiaLymphoma, FollicularHypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Ulla Kristine Møller Liendgaard, Phd, MHSc.

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 27, 2017

Study Start

October 24, 2017

Primary Completion

August 28, 2020

Study Completion

August 28, 2020

Last Updated

January 6, 2021

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(3)