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Chronic Remote Ischemic Preconditioning as a Complement to Conventional Prenatal Care for Preeclampsia

NCT05564988 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-10-04

No results posted yet for this study

Summary

Pre-eclampsia is a disease specific to pregnancy that affects 3-5% of women. It is defined by the appearance of high blood pressure after 20 weeks of amenorrhea associated with the presence of proteins in the urine, dysfunction of organs such as the liver, kidneys, lungs or brain, or dysfunction of the placenta. The cause of this disease is still unclear but it would most likely be a placental origin. Pre-eclampsia is a progressive disease that can lead to important complications. To date, there is no treatment for pre-eclampsia other than childbirth and more particularly placental delivery. Nevertheless, it is possible in some cases to stabilize arterial hypertension and thus to hope for a prolongation of the pregnancy.

Our research project aims to study the effect of preconditioning on blood pressure.

Preconditioning consists of using a blood pressure cuff and inflating it on the upper limb -like during a standard blood pressure measurement- for several minutes followed by a rest period in order to create "ischemia-reperfusion" periods. This technique would allow the release of beneficial substances into the bloodstream that would lower blood pressure. This method has been used for several years in different specialties and has produced good results on the heart, kidneys, lungs and brain.

With this technique we hope to stabilize or even reduce blood pressure in cases of pre-eclampsia and thus prolong the pregnancy.

Conditions

Interventions

OTHER

Preconditionning

Remote ischemic conditioning will be induced using a Tourniquet cuff applied to the patient's non-dominant arm. The device used will be an Ulrich Kariba machine. A strip of absorbent cotton will be applied to the arm and the tension cuff will be placed over it in a standard way. The systolic pressure and the application time will be set manually. Ischemia will be obtained after inflating the cuff to a pressure of 200 mmHg (or a pressure at least 50 mmHg above the patient's systolic pressure). After a five-minute period, the cuff will be deflated and the arm allowed to reperfuse for five minutes. These maneuvers will be repeated until 3 cycles of ischemia- reperfusion have been completed once a day. Patients will experiment with this procedure for at least 5 days.

Sponsors & Collaborators

  • DAVID DESSEAUVE

    lead OTHER

Principal Investigators

  • Hélène Legardeur · CHUV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2025-10-31
Completion
2026-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05564988 on ClinicalTrials.gov