Back to resultsChronic Remote Ischemic Preconditioning as a Complement to Conventional Prenatal Care for Preeclampsia (RIPC)
Primary Purpose
Preeclampsia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Preconditionning
Sponsored by
About this trial
This is an interventional treatment trial for Preeclampsia focused on measuring Preconditioning
Eligibility Criteria
Inclusion Criteria:
- Singleton pregnancy
- Gestational age between 24 0/7 and 36 6/7 weeks' gestation
- Hospitalization for non-severe pre-eclampsia (non-severe hypertension = Systolic blood pressure between 140 and 160mmHg, diastolic blood pressure between 90 and 110mmHg associated with one of these: proteinuria >=300mg/24h/thrombocytopenia 100-150G/L/central symptoms such as headache responding to standard analgesics/hyperreflexia without clonus/decreased fibrinogen/haptoglobin <0.1/utero-placental dysfunction with IUGR and/or umbilical Doppler Class II)
- Maternal age >18 years
- Good comprehension of French allowing easy understanding of the information protocol and the consent form
Exclusion Criteria:
- Chronic hypertension
- Renal disease
- Pre-pregnancy diabetes
- Autoimmune disease (SAPL, SLE, Sjögren)
- Severe PE (Systolic blood pressure >160mmHg, diastolic blood pressure >140mmHg, hepatic cytolysis at twice the norm, right hypochondrium or epigastric pain, central symptoms such as clonus or headache resistant to usual treatment or disturbed consciousness, thrombocytopenia <100G/L, acute pulmonary edema, renal failure defined by doubling of baseline creatinine value or creatinine >97 micromol/L)
- Suspected fetal anomaly or malformation
- HELLP syndrome
- Eclampsia attack
- Pathological fetal monitoring
- Known maternal upper limb vascular anomaly
- Severe maternal cardiac pathology
- Maternal history of deep vein thrombosis of the upper limb
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Preconditionning
Control
Arm Description
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.
For subjects assigned to the control group, the pneumatic cuff is placed around the upper arm, and inflation of a blood pressure to a lower pressure (50mmHg) which will result in no impairment of antegrade flow.
Outcomes
Primary Outcome Measures
Decrease blood pressure
Comparison of mean of decrease in systolic and diastolic blood pressure (intervention vs placebo) between day 1 and day 5 using ANOVA test
Decreased blood pressure patients
Comparison of the number of patients who significantly decreased blood pressures (≥6%), Chi-squared test or Fisher exact test if appropriate
Secondary Outcome Measures
SFLT/PLGF change
Comparison of mean change in the SFLT/PLGF ratio
Uterine artery resistance index change
Comparison of mean change in the uterine artery resistance index (using ANOVA test)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05564988
Brief Title
Chronic Remote Ischemic Preconditioning as a Complement to Conventional Prenatal Care for Preeclampsia
Acronym
RIPC
Official Title
Chronic Remote Ischemic Preconditioning as a Complement to Conventional Prenatal Care for Preeclampsia: a One-center Prospective Randomized Study for Women With Non-severe Preeclampsia Between 24 and 37 Weeks' Gestation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
DAVID DESSEAUVE
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Preconditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preconditionning
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
For subjects assigned to the control group, the pneumatic cuff is placed around the upper arm, and inflation of a blood pressure to a lower pressure (50mmHg) which will result in no impairment of antegrade flow.
Intervention Type
Other
Intervention Name(s)
Preconditionning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease blood pressure
Description
Comparison of mean of decrease in systolic and diastolic blood pressure (intervention vs placebo) between day 1 and day 5 using ANOVA test
Time Frame
Up to 13 weeks
Title
Decreased blood pressure patients
Description
Comparison of the number of patients who significantly decreased blood pressures (≥6%), Chi-squared test or Fisher exact test if appropriate
Time Frame
Up to 13 weeks
Secondary Outcome Measure Information:
Title
SFLT/PLGF change
Description
Comparison of mean change in the SFLT/PLGF ratio
Time Frame
Up to 13 weeks
Title
Uterine artery resistance index change
Description
Comparison of mean change in the uterine artery resistance index (using ANOVA test)
Time Frame
Up to 13 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Singleton pregnancy
Gestational age between 24 0/7 and 36 6/7 weeks' gestation
Hospitalization for non-severe pre-eclampsia (non-severe hypertension = Systolic blood pressure between 140 and 160mmHg, diastolic blood pressure between 90 and 110mmHg associated with one of these: proteinuria >=300mg/24h/thrombocytopenia 100-150G/L/central symptoms such as headache responding to standard analgesics/hyperreflexia without clonus/decreased fibrinogen/haptoglobin <0.1/utero-placental dysfunction with IUGR and/or umbilical Doppler Class II)
Maternal age >18 years
Good comprehension of French allowing easy understanding of the information protocol and the consent form
Exclusion Criteria:
Chronic hypertension
Renal disease
Pre-pregnancy diabetes
Autoimmune disease (SAPL, SLE, Sjögren)
Severe PE (Systolic blood pressure >160mmHg, diastolic blood pressure >140mmHg, hepatic cytolysis at twice the norm, right hypochondrium or epigastric pain, central symptoms such as clonus or headache resistant to usual treatment or disturbed consciousness, thrombocytopenia <100G/L, acute pulmonary edema, renal failure defined by doubling of baseline creatinine value or creatinine >97 micromol/L)
Suspected fetal anomaly or malformation
HELLP syndrome
Eclampsia attack
Pathological fetal monitoring
Known maternal upper limb vascular anomaly
Severe maternal cardiac pathology
Maternal history of deep vein thrombosis of the upper limb
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maud Vachette
Phone
+41795568781
Email
maud.vachette@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Legardeur
Organizational Affiliation
CHUV
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Chronic Remote Ischemic Preconditioning as a Complement to Conventional Prenatal Care for Preeclampsia
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