Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section

The goal of this project is to examine the cardiac symptoms and physiologic changes after administration of a reduced dose of carbetocin in participants undergoing elective cesarian section.

• Does reduced dose carbetocin (50mcg) have fewer cardiac side effects than usual dose carbetocin (100mcg) when comparing patient reported symptoms, ECG changes and troponin increases?
• Is there a relationship between patient reported cardiac symptoms after carbetocin administration and subjective measures of cardiac ischemia (ECG changes and troponin increases? Researchers will compare 50mcg of carbetocin to the control group of 100mcg of carbetocin in patients undergoing elective cesarian section.

Participants will:

• Be given 50mcg or 100mcg of carbetocin during cesarian section
• Asked to report cardiac symptoms
• Be assessed for ECG changes and blood loss using standard of practice monitoring
• Have a troponin I blood test completed after delivery

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Ischemia; Cesarian Section
• Intervention / Treatment: Drug: Carbetocin

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jordan Leitch, MD; Phone Number: 613-549-6666; Email: jordan.leitch@kingstonhsc.ca
• Study Contact Backup: Name: Taylor Perry, MD; Phone Number: (613) 548-3232; Email: taylorchristina.perry@kingstonHSC.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre
      • Contact: Taylor C. M. Perry; Phone Number: (613) 548-3232; Email: taylorchristina.perry@kingstonHSC.ca
      • Contact: Jordan Leitch; Email: jordan.leitch@kingstonHSC.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Undergoing elective cesarian section
• Primary and repeat cesarian section

Exclusion Criteria:

• Prior and current cardiovascular co-morbidities including pre-eclampsia
• BMI greater than 50
• Pre-existing bleeding disorders
• Allergy to carbetocin
• Age under 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50mcg of Carbetocin; Participants in this arm will receive 50mcg of carbetocin for post party hemorrhage prophylaxis at the the time of umbilical cord clamping during their cesarian section.	Drug: Carbetocin; A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section
Active Comparator: 100mcg of Carbetocin; Participants in this arm will receive 100mcg of carbetocin for post party hemorrhage prophylaxis at the the time of umbilical cord clamping during their cesarian section.	Drug: Carbetocin; A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported symptoms	Subjective patient reported symptoms of cardiac ischemia, reported with descriptive words	within 5 minutes of study drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Troponin I levels	Troponin I levels on blood work	One day after study drug administration
ECG: ST segment	Changes to the ST segment on ECG	5 minutes after study drug administration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss during surgery	Recorded from anesthesiologists assessment	Within 1 hour of study drug administration
Surgeons assessment of uterine tone	Assessed as a binary of adequate or not adequate	3 minutes after study drug administration
Hemoglobin change	Assessed as a difference between preoperative and postoperative hemoglobin	Preoperatively and one day postoperatively

Collaborators and Investigators

• Sponsor: Jordan Leitch
• Investigators: Principal Investigator: Jordan Leitch, MD, Kingston Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: carbetocin; duratocin; cardiac symptoms
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Carbetocin
• Other Study ID Numbers: 69135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No