About this trial
This observational study aims to compare mean arterial pressure measurements obtained using an ankle blood pressure cuff with those obtained using a standard upper-arm cuff in pregnant individuals undergoing elective cesarean delivery under spinal anesthesia. The primary objective is to determine the level of agreement between the two measurement sites.The main question\[s\] it aims to answer \[is/are\]:
Demonstrate that the mean arterial pressure is similar between arm and ankle with the blood pressure cuff
Every participant will be their own control. (Measurements will be taken at both sites on every participant)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women scheduled for elective cesarean under neuraxial anesthesia at CHU Sainte-Justine.
American Society of Anesthesiologists Physical Status I-III
Singleton pregnancy
Gestation ≥ 35 weeks
Disqualifiers
Cesarean planned under general anesthesia.
Multiple pregnancy
Prematurity < 35 weeks gestation
Major fetal anomalies
Trial population
The target population will be adult pregnant women scheduled for elective cesarean delivery at CHU Sainte-Justine.
Trial design
Cohort
Prospective
Treatments tested in this trial
Mean arterial pressure
DeviceMean arterial pressure will be taken on the arm and on the ankle from the same patient and compared.
Treatment groups
Trial outcomes
Primary outcomes
Comparison of mean arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after birth.
Comparison of mean arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after birth. This is to measure the outcome at a time point compatible with skin-to-skin for the mother-baby dyad.
Secondary outcomes
Comparison in mean, systolic, diastolic arterial pressure taken by appropriately sized pressure cuffs between arm and ankle before neuraxial anesthesia, in the holding area.
Comparison in mean arterial pressure taken by appropriately sized pressure cuffs between arm and ankle before neuraxial anesthesia, in the holding area. This is is to compare the blood pressure before any intervention was made, and to observe it a difference already exists.
Comparison of mean, systolic, diastolic arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after neuraxial anesthesia.
Comparison of mean, systolic, diastolic arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after neuraxial anesthesia. This is to evaluate if the two measurements are comparable when under neuraxial anesthesia with a vasopressor infusion.
Comparison in mean, systolic, diastolic arterial pressure taken by appropriately sized pressure cuffs between arm and ankle 10, 15, 20 minutes after birth.
Comparison in mean, systolic, diastolic arterial pressure taken by appropriately sized pressure cuffs between arm and ankle 10, 15, 20 minutes after birth. This is to determine if the blood pressure is comparable between arm and ankle for several time points after birth.
Assess maternal comfort and ease of skin-to-skin application with each blood pressure cuff (on the ankle and on the arm)
Assess maternal comfort and ease of skin-to-skin application with each blood pressure cuff (on the ankle and on the arm) with a questionnaire containing these questions : 1. Did the arm BP cuff cause you discomfort or pain? 2. Did the ankle BP cuff cause you discomfort or pain? 3. Did the arm BP cuff limit your ability to hold your newborn as you wished? 4. Did the ankle BP cuff limit your ability to hold your newborn as you wished?
Sponsors and contacts
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St. Justine's Hospital
Lead sponsor
Université de Montréal
Collaborator