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

NCT05564988 | Not Yet Recruiting DMC

• 1 other identifier: 2021-01516
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preeclampsia

Keywords

Preconditioning

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• SFLT/PLGF change

  Up to 13 weeks

• Uterine artery resistance index change

  Up to 13 weeks

Study Arms (2)

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.

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.

Interventions

Preconditionning OTHER

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.

Preconditionning

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DAVID DESSEAUVE: lead

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hélène Legardeur

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maud Vachette

CONTACT

+41795568781; maud.vachette@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of delivery room

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 4, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: February 1, 2026
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share