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Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study (CaRDIO)

University of British Columbia logo

University of British Columbia

Status and phase

Completed
Phase 4

Conditions

Cardiac Arrythmias

Treatments

Drug: Carbetocin

Study type

Interventional

Funder types

Other

Identifiers

NCT03716076
H18-02232

Details and patient eligibility

About

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

Full 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

Enrollment

50 patients

Sex

Female

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Participant receives 50 mcg of carbetocin post-delivery.
Experimental group
Description:
Participant receives 50 mcg of carbetocin post-delivery.
Treatment:
Drug: Carbetocin
Participant receives 100 mcg of carbetocin post-delivery.
Experimental group
Description:
Participant receives 100 mcg of carbetocin post-delivery.
Treatment:
Drug: Carbetocin

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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