Actively Recruiting

Age: 18Years +
FEMALE
ID07422766

Observational Study Comparing Non-Invasive Mean Arterial Blood Pressure Measurements at the Arm and Ankle During Elective Cesarean Delivery to Facilitate Skin-to-Skin Contact

Led by St. Justine's Hospital · Updated on 2026-03-27

110

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

St. Justine's Hospital

Lead Sponsor

U

Université de Montréal

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare blood pressure measurements taken on the ankle with those taken on the arm in pregnant women undergoing elective cesarean delivery under spinal anesthesia. The main goal is to see if the mean arterial pressure (MAP) readings from the ankle are similar to the standard arm measurements, especially five minutes after birth when skin-to-skin contact is encouraged. This observational study includes women at 35 weeks or more of pregnancy scheduled for cesarean delivery. Participants will have two non-invasive blood pressure cuffs placed simultaneously: one on the arm and one on the ankle. Measurements will be taken before neuraxial anesthesia in the waiting room, five minutes after spinal anesthesia, and five minutes after birth. The study also evaluates maternal comfort and ease of holding the newborn with each cuff by asking four yes/no questions after surgery. During the study, researchers will collect blood pressure data at these key times along with demographics and newborn information. Maternal comfort regarding the blood pressure cuffs and the ability to hold the baby skin-to-skin will be assessed. Data will be analyzed to compare blood pressure readings and understand any differences. Participation involves standard care with added ankle blood pressure monitoring and lasts from enrollment through the end of the surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women scheduled for elective cesarean under neuraxial anesthesia at CHU Sainte-Justine
  • American Society of Anesthesiologists Physical Status I-III
  • Singleton pregnancy
  • Gestation 65 35 weeks
  • BMI < 40
  • Able to consent in French or English
Not Eligible

You will not qualify if you...

  • Cesarean planned under general anesthesia
  • Multiple pregnancy
  • Prematurity < 35 weeks gestation
  • Major fetal anomalies
  • Morbid obesity (BMI 65 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.)

AI-Screening

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Your Study Journey

Screening

Duration - Up to the day of surgery

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) before surgery for consent and eligibility confirmation

Monitoring During Elective Cesarean Delivery

Duration - On the day of surgery, during the cesarean delivery

Participants have blood pressure measured simultaneously on the arm and ankle before neuraxial anesthesia, five minutes after neuraxial anesthesia, and five minutes after birth to compare measurements and assess maternal comfort with each cuff.

1 visit (in-person) on the day of surgery including measurements before anesthesia, after anesthesia, and post-birth

Trial Site Locations

Total: 1 location

1

CHU Sainte-Justine

Montreal, Quebec, Canada, H3T 1C5

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Research Team

V

Valerie Zaphiratos, MD, MSc, FRCPC, Anesthesiology

M

Marc Leclerc, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial