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Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).
Carbetocin is a uterotonic used to prevent postpartum hemorrhage. Although it has been proven to be completely safe, little is known about its effects on the electrical activity of the heart. The investigators aim to determine its effect on myocardial repolarization dynamics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant receives 50 mcg of carbetocin post-delivery. | Experimental | Participant receives 50 mcg of carbetocin post-delivery. |
|
| Participant receives 100 mcg of carbetocin post-delivery. | Experimental | Participant receives 100 mcg of carbetocin post-delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbetocin | Drug | 50 mcg or 100 mcg bolus of carbetocin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tp-e | Time interval between peak and end of T-wave (Tp-e) | 5 minutes post-carbetocin administration |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia | Occurrence of Atrial or Ventricular Arrhythmias | perioperatively, typically ranging 30 minutes-1 hour |
| QTc at 5 Min | Bazette corrected Q-T interval |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anton Chau, MD MMSc | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Women's Hospital | Vancouver | British Columbia | V6H 3N1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32149759 | Derived | Clunies-Ross N, Roston TM, Taylor J, Whyte S, Albert A, Gorges M, Chau A. The Effect of Carbetocin Dose on Transmural Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia: A Prospective, Randomized Clinical Trial. Anesth Analg. 2021 Feb 1;132(2):485-492. doi: 10.1213/ANE.0000000000004712. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participant Receives 50 mcg of Carbetocin Post-delivery. | Participant receives 50 mcg of carbetocin post-delivery. Carbetocin: 50 mcg or 100 mcg bolus of carbetocin |
| FG001 | Participant Receives 100 mcg of Carbetocin Post-delivery. | Participant receives 100 mcg of carbetocin post-delivery. Carbetocin: 50 mcg or 100 mcg bolus of carbetocin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participant Receives 50 mcg of Carbetocin Post-delivery. | Participant receives 50 mcg of carbetocin post-delivery. Carbetocin: 50 mcg or 100 mcg bolus of carbetocin |
| BG001 | Participant Receives 100 mcg of Carbetocin Post-delivery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tp-e | Time interval between peak and end of T-wave (Tp-e) | Posted | Mean | Standard Deviation | milliseconds | 5 minutes post-carbetocin administration |
|
2 days, which is the typical time spent in hospital for monitoring after cesarean sections
Participants are screened for a history of intolerance to oxytocin, which puts them at low risk of intolerance/mortality or serious adverse reaction to carbetocin.
Patients are monitored for minor adverse events, such as arrhythmia, which are potential side effects of carbetocin dosing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participant Receives 50 mcg of Carbetocin Post-delivery. | Participant receives 50 mcg of carbetocin post-delivery. Carbetocin: 50 mcg or 100 mcg bolus of carbetocin |
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No data exists that stratifies risk by measuring absolute Tp-e change We excluded patients with low repolarization reserves, or a resistance to oxytocin. We also excluded emergent C-sections, combined spinal/epidurals, and General Anesthesia
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Chau | BC Women's Hospital | 604-875-2158 | anton.chau@ubc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2019 | Apr 7, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2019 | Apr 7, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C020731 | carbetocin |
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| 5 min post-carbetocin administration |
| QTc 10 Min | Bazette corrected Q-T interval (QTc) | 10 minutes post-carbetocin administration |
| QTc 5 Min Spinal | Bazette corrected Q-T interval change after spinal anesthesia | 5 min post-administration of spinal anesthesia |
| Tp-e 5 Min Post-spinal | Time between peak and end of T-wave, | 5 minutes after administration of spinal anesthesia |
| Tp-e at 10 Min | Time between peak and end of T-wave | 10 minutes post-carbetocin administration |
Participant receives 100 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean Arterial Pressure | Mean | Standard Deviation | mmHg |
|
| Heart Rate | Mean | Standard Deviation | bpm |
|
| Gravida | Median | Inter-Quartile Range | pregnancies |
|
| Parity of 0 | Number | participants |
|
| Gestational Age | Mean | Standard Deviation | weeks |
|
| Parity greater than 0 | Number | participants |
|
| Baseline QTc | Baseline Bazett-corrected Q-T interval | Mean | Standard Deviation | milliseconds |
|
| Baseline Tp-e | Time between peak and end of T-wave | Mean | Standard Deviation | milliseconds |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| Phenylephrine Dose | Mean | Standard Deviation | micrograms |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Arrhythmia | Occurrence of Atrial or Ventricular Arrhythmias | Posted | Count of Participants | Participants | perioperatively, typically ranging 30 minutes-1 hour |
|
|
|
| Secondary | QTc at 5 Min | Bazette corrected Q-T interval | Posted | Mean | Standard Deviation | milliseconds | 5 min post-carbetocin administration |
|
|
|
| Secondary | QTc 10 Min | Bazette corrected Q-T interval (QTc) | Posted | Mean | Standard Deviation | milliseconds | 10 minutes post-carbetocin administration |
|
|
|
| Secondary | QTc 5 Min Spinal | Bazette corrected Q-T interval change after spinal anesthesia | Posted | Mean | Standard Deviation | milliseconds | 5 min post-administration of spinal anesthesia |
|
|
|
| Secondary | Tp-e 5 Min Post-spinal | Time between peak and end of T-wave, | Posted | Mean | Standard Deviation | milliseconds | 5 minutes after administration of spinal anesthesia |
|
|
|
| Secondary | Tp-e at 10 Min | Time between peak and end of T-wave | Posted | Mean | Standard Deviation | milliseconds | 10 minutes post-carbetocin administration |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Participant Receives 100 mcg of Carbetocin Post-delivery. | Participant receives 100 mcg of carbetocin post-delivery. Carbetocin: 50 mcg or 100 mcg bolus of carbetocin | 0 | 25 | 0 | 25 | 0 | 25 |
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