Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carbetocin.
- Who it may be relevant to
- Registry conditions: Cardiac Ischemia, Cesarian Section. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug Carbetocin
A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section
Primary outcome measures
- Patient reported symptoms [Time frame: within 5 minutes of study drug administration]
Secondary outcome measures (2)
- Troponin I levels [Time frame: One day after study drug administration]
- ECG: ST segment [Time frame: 5 minutes after study drug administration]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Kingston Health Sciences Centre — Kingston
Identifiers
NCT: NCT06946589 · 69135