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

Preeclampsia Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05564988
• Other study ID #: 2021-01516
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: February 2026

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Maud Vachette
• Phone: +41795568781
• Email: maud.vachette[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: February 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DAVID DESSEAUVE

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 13 weeks
Primary	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	Up to 13 weeks
Secondary	SFLT/PLGF change	Comparison of mean change in the SFLT/PLGF ratio	Up to 13 weeks
Secondary	Uterine artery resistance index change	Comparison of mean change in the uterine artery resistance index (using ANOVA test)	Up to 13 weeks