Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study
CaRDIO
The Effect of Carbetocin Dose on Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia
1 other identifier
interventional
50
1 country
1
Brief Summary
Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2020
CompletedResults Posted
Study results publicly available
May 14, 2021
CompletedMay 14, 2021
April 1, 2021
8 months
October 17, 2018
September 8, 2020
April 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tp-e
Time interval between peak and end of T-wave (Tp-e)
5 minutes post-carbetocin administration
Secondary Outcomes (6)
Arrhythmia
perioperatively, typically ranging 30 minutes-1 hour
QTc at 5 Min
5 min post-carbetocin administration
QTc 10 Min
10 minutes post-carbetocin administration
QTc 5 Min Spinal
5 min post-administration of spinal anesthesia
Tp-e 5 Min Post-spinal
5 minutes after administration of spinal anesthesia
- +1 more secondary outcomes
Study Arms (2)
Participant receives 50 mcg of carbetocin post-delivery.
EXPERIMENTALParticipant receives 50 mcg of carbetocin post-delivery.
Participant receives 100 mcg of carbetocin post-delivery.
EXPERIMENTALParticipant receives 100 mcg of carbetocin post-delivery.
Interventions
50 mcg or 100 mcg bolus of carbetocin
Eligibility Criteria
You may qualify if:
- Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial anesthesia
- American Society of Anesthesiologists (ASA) class 2
- Patients ≥ 19 years of age
You may not qualify if:
- Long QT syndrome
- Cardiac disease or rhythm abnormalities
- Family history of long QT syndrome or abnormal cardiac conduction
- Currently taking medication that is known to prolong the QT interval
- Women who are high risk for uterine atony as outlined in SOGC
- Known allergic reaction or hypersensitivity to Carbetocin or any other oxytocin homologue
- Patients who are unable to give informed consent because of a language barrier as the study team only speaks English and will be unable to complete consent process and study procedure appropriately.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Women's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
Related Publications (1)
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.
PMID: 32149759DERIVED
MeSH Terms
Interventions
Limitations and Caveats
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
Results Point of Contact
- Title
- Dr. Anthony Chau
- Organization
- BC Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Anton Chau, MD MMSc
University of British Columbia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
October 17, 2018
First Posted
October 23, 2018
Study Start
November 1, 2018
Primary Completion
June 15, 2019
Study Completion
April 24, 2020
Last Updated
May 14, 2021
Results First Posted
May 14, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share