Comparison of Non-Invasive Mean Arterial Blood Pressure Measurements at the Arm and Ankle During Elective Cesarean Delivery.

NCT07422766 | Recruiting DMC

• 1 other identifier: 2026-9782
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Cesarean Delivery; Blood Pressure Measurement in Pregnancy; Skin to Skin Contact; Pregnancy

Keywords

blood pressure; Mean arterial pressure; pregnancy; cesarean; skin to skin

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment (in the waiting room) to end of surgery

Secondary Outcomes (3)

• Comparison in mean arterial pressure taken by appropriately sized pressure cuffs between arm and ankle before neuraxial anesthesia, in the waiting room

  From the waiting room to before neuraxial anesthesia

• Comparison in mean arterial pressure taken by appropriately sized pressure cuffs between arm and ankle 10 minutes after neuraxial anesthesia.

  10 minutes after neuraxial anesthesia

• Assess maternal comfort and ease of skin-to-skin application with each blood pressure cuff (on the ankle and on the arm)

  From enrollment in the waiting room to end of surgery

Study Arms (1)

Cesarean delivery patients

Patients will have a blood pressure cuff on the arm and the ankle.

Device: Mean arterial pressure

Interventions

Mean arterial pressure DEVICE

Mean arterial pressure will be taken on the arm and on the ankle from the same patient and compared.

Cesarean delivery patients

Eligibility Criteria

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

Study Population

The target population will be adult pregnant women scheduled for elective cesarean delivery at CHU Sainte-Justine.

You may qualify if:

• 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
• BMI \< 40
• Able to consent in French or English

You may not qualify if:

• Cesarean planned under general anesthesia.
• Multiple pregnancy
• Prematurity \< 35 weeks gestation
• Major fetal anomalies
• Morbid obesity (BMI ≥ 40)
• Active labor
• Emergency cesarean
• Prisoners
• Peripheral vascular disease requiring medication or treatment
• Hypertensive diseases requiring medication
• Inability to place blood pressure cuff on ankle (amputation, dysmorphism, etc.)
• Complications requiring significant hemodynamic support (transfusions, inotropes, multiple vasopressors, etc.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Université de Montréal: collaborator

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Related Publications (1)

• Drake MJ, Hill JS. Observational study comparing non-invasive blood pressure measurement at the arm and ankle during caesarean section. Anaesthesia. 2013 May;68(5):461-6. doi: 10.1111/anae.12194. Epub 2013 Mar 11.

  PMID: 23480469 BACKGROUND

Study Officials

• Valerie Zaphiratos

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Zaphiratos, MD, MSc, FRCPC, Anesthesiology

CONTACT

15143454931; valerie@zaphiratos.ca

Marc Leclerc, MD

CONTACT

15143454931; marc.leclerc.3@umontreal.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 20, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)