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Trial record 1 of 1 for:    "Cardiac Arrhythmia" | "Carbetocin"
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Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study (CaRDIO)

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ClinicalTrials.gov Identifier: NCT03716076
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Anton Chau, University of British Columbia

Brief Summary:
Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).

Condition or disease Intervention/treatment Phase
Cardiac Arrythmias Drug: Carbetocin Phase 4

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Effect of Carbetocin Dose on Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
C50
Participant receives 50 mcg of carbetocin post-delivery.
Drug: Carbetocin
50 mcg or 100 mcg bolus of carbetocin

C100
Participant receives 100 mcg of carbetocin post-delivery.
Drug: Carbetocin
50 mcg or 100 mcg bolus of carbetocin




Primary Outcome Measures :
  1. Cardiac repolarization dynamics [ Time Frame: 5 minutes post-carbetocin administration ]
    cardiac repolarization indices on ECG - QTc interval



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial anesthesia
  • American Society of Anesthesiologists (ASA) class 2
  • Patients ≥ 19 years of age

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716076


Contacts
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Contact: James D Taylor, BSc 604-875-2424 ext 6076 james.taylor1@phsa.ca
Contact: Natasha G Clunies-Ross, BSc MBBS 604-875-2424 ext 6076 natasha.cluniesross@cw.bc.ca

Locations
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Canada, British Columbia
BC Women's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: James D Taylor, BSc    604-875-2424 ext 6076    james.taylor1@phsa.ca   
Contact: Natasha G Clunies-Ross, MBBS FRCA    604-875-2424 ext 6076    natasha.cluniesross@cw.bc.ca   
Principal Investigator: Anton Chau, MD MMSc         
Sub-Investigator: Natasha Clunies-Ross, MBBS         
Sub-Investigator: Thomas Roston, MD         
Sub-Investigator: James Taylor, BSc         
Sub-Investigator: Simon Whyte, MBBS         
Sub-Investigator: Matthias Gorges, PhD         
Sub-Investigator: Arianne Albert, PhD         
Sub-Investigator: Giselle Villar, MD FRCPC         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Anton Chau, MD MMSc University of British Columbia

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Responsible Party: Anton Chau, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03716076     History of Changes
Other Study ID Numbers: H18-02232
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anton Chau, University of British Columbia:
Carbetocin
Myocardial repolarization
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Carbetocin
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs