PreeclampsiaRIPCNCT05564988
Chronic Remote Ischemic Preconditioning as a Complement to Conventional Prenatal Care for Preeclampsia
A study testing Preconditionning in people with Preeclampsia, run by DAVID DESSEAUVE.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Preconditionning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read more
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
- Preeclampsia
- Being tested
- Preconditionning
- Keywords
- Preconditioning
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreconditionningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Preconditionning | Experimental | 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. Receives: Other: Preconditionning |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 13 weeks
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
Measured: Up to 13 weeks
Secondary outcomes (2)
SFLT/PLGF change
Comparison of mean change in the SFLT/PLGF ratio
Measured: Up to 13 weeks
Uterine artery resistance index change
Comparison of mean change in the uterine artery resistance index (using ANOVA test)
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DAVID DESSEAUVE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DAVID DESSEAUVE, Centre Hospitalier Universitaire Vaudois
- Investigators
- Hélène Legardeur, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564988
- Sponsor's protocol ID
- 2021-01516
- Acronym
- RIPC
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05564988
- Acronym / sponsor ID
- RIPC / 2021-01516
- Conditions
- Preeclampsia
- Keywords
- Preconditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- DAVID DESSEAUVEUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preconditionning | Experimental | Other: PreconditionningIschemia 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreconditionningRemote 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. | Other | Preconditionning |
Primary outcome
Decrease blood pressure
Time frame: Up to 13 weeks
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
Time frame: Up to 13 weeks
Comparison of the number of patients who significantly decreased blood pressures (≥6%), Chi-squared test or Fisher exact test if appropriate
2 secondary outcomes
SFLT/PLGF change
Time frame: Up to 13 weeks
Uterine artery resistance index change
Time frame: Up to 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Legardeur principal investigator
CHUV
Questions about this trial
What is this clinical trial studying?
A study testing Preconditionning in people with Preeclampsia, run by DAVID DESSEAUVE.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maud Vachette (+41795568781, maud.vachette@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease blood pressure (time frame: Up to 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.