Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section

Phase 4

Not yet recruiting

• Conditions: Cardiac Ischemia; Cesarian Section
• Interventions: Drug: Carbetocin

• Registration Number: NCT06946589
• Lead Sponsor: Jordan Leitch

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-20
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-20
• Last Update Submitted: 2025-04-20
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27
• Study Start: 2025-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50mcg of Carbetocin	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	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.

Primary Outcome Measures

Name	Time	Method
Patient reported symptoms	within 5 minutes of study drug administration	Subjective patient reported symptoms of cardiac ischemia, reported with descriptive words

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada