Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section
NCT ID: NCT06946589
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2025-08-01
2027-09-01
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Carbetocin
A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section
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.
Carbetocin
A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section
Interventions
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Carbetocin
A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section
Eligibility Criteria
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Inclusion Criteria
* Primary and repeat cesarian section
Exclusion Criteria
* BMI greater than 50
* Pre-existing bleeding disorders
* Allergy to carbetocin
* Age under 18
18 Years
FEMALE
No
Sponsors
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Jordan Leitch
OTHER
Responsible Party
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Jordan Leitch
Dr. Jordan Leitch, Assistant Professor, Dept. of Anesthesiology/Critical Care, Queen's University
Principal Investigators
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Jordan Leitch, MD
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Locations
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Kingston Health Sciences Centre
Kingston, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69135
Identifier Type: -
Identifier Source: org_study_id
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