Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study

Phase 4

Completed

• Conditions: Cardiac Arrythmias
• Interventions: Drug: Carbetocin

• Registration Number: NCT03716076
• Lead Sponsor: University of British Columbia

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-19
• Study First Posted: 2018-10-23
• Study Start: 2018-11-01
• Primary Completion: 2019-06-15
• Study Completion: 2020-04-24
• Results First Submitted: 2020-09-08
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Results First Posted: 2021-05-14
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participant receives 50 mcg of carbetocin post-delivery.	Carbetocin	Participant receives 50 mcg of carbetocin post-delivery.
Participant receives 100 mcg of carbetocin post-delivery.	Carbetocin	Participant receives 100 mcg of carbetocin post-delivery.

Primary Outcome Measures

Name	Time	Method
Tp-e	5 minutes post-carbetocin administration	Time interval between peak and end of T-wave (Tp-e)

Secondary Outcome Measures

Name	Time	Method
Tp-e 5 Min Post-spinal	5 minutes after administration of spinal anesthesia	Time between peak and end of T-wave,
QTc at 5 Min	5 min post-carbetocin administration	Bazette corrected Q-T interval
QTc 10 Min	10 minutes post-carbetocin administration	Bazette corrected Q-T interval (QTc)
Tp-e at 10 Min	10 minutes post-carbetocin administration	Time between peak and end of T-wave
QTc 5 Min Spinal	5 min post-administration of spinal anesthesia	Bazette corrected Q-T interval change after spinal anesthesia
Arrhythmia	perioperatively, typically ranging 30 minutes-1 hour	Occurrence of Atrial or Ventricular Arrhythmias

Trial Locations

Locations (1)

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada