Recruiting

Observational Study

Sponsor:

St. Justine's Hospital

Code:

NCT07422766

Conditions

Pregnancy

Cesarean Delivery

Blood Pressure Measurement in Pregnancy

Skin to Skin Contact

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mean arterial pressure

Study Details

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

Pregnancy

Cesarean Delivery

Blood Pressure Measurement in Pregnancy

Skin to Skin Contact

Study ID

NCT07422766

Start date

Feb 26, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

110 participants

Anticipated

Interventions and Outcome Measures

Arms

Cesarean delivery patients

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

Interventions

Mean arterial pressure

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

Primary outcome measure

  • Comparison of mean arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after birth. [ Time Frame: From enrollment (in the waiting room) to end of surgery ]

Central Contacts and Locations

Central contacts

Valerie Zaphiratos, MD, MSc, FRCPC, Anesthesiology

15143454931valerie@zaphiratos.ca

Marc Leclerc, MD

15143454931marc.leclerc.3@umontreal.ca

Locations

CHU Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Valerie Zaphiratos

5146684778valerie@zaphiratos.ca

More Information

Sponsor

St. Justine's Hospital

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2026-08-07.