Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section

NCT06946589 — Phase 4, Not yet recruiting, 200 participants, Jordan Leitch

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Registry	NCT06946589
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	200 (Estimated)
Sponsor	Jordan Leitch (Other)
Conditions	Cardiac Ischemia, Cesarian Section
Interventions	Carbetocin (Drug)
Dates	start 2025-08-01 (estimated), primary completion 2026-08-01 (estimated), completion 2027-09-01 (estimated), first posted 2025-04-27, last updated 2025-04-27
Locations	1 site in Canada

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
50mcg of Carbetocin	Experimental	Drug: 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.
100mcg of Carbetocin	Active comparator	Drug: 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.

Carbetocin (Drug): A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section

+Outcome measures

Primary outcomes

Patient reported symptoms [within 5 minutes of study drug administration]: Subjective patient reported symptoms of cardiac ischemia, reported with descriptive words

Secondary outcomes

Troponin I levels [One day after study drug administration]: Troponin I levels on blood work
ECG: ST segment [5 minutes after study drug administration]: Changes to the ST segment on ECG

Other outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Kingston Health Sciences Centre	Kingston, Ontario	Canada

+Investigators

Jordan Leitch, MD, Principal investigator, Queen's University