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CompletedNCT03716076CaRDIOUpdated May 14, 2021Results posted

Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study

A Phase 4 interventional study of Carbetocin in Cardiac Arrythmias, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to female participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-14.

Sponsored by University of British Columbia · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
19 Years and older
Sex
Female
01

Study summary

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

Read the 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

02

Conditions studied

  • Cardiac Arrythmias

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Keywords

  • Carbetocin
  • Myocardial repolarization
03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's enrollment of 50 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Participant receives 50 mcg of carbetocin post-delivery.

    Participant receives 50 mcg of carbetocin post-delivery.

    Drug: Carbetocin

  • Experimental
    Participant receives 100 mcg of carbetocin post-delivery.

    Participant receives 100 mcg of carbetocin post-delivery.

    Drug: Carbetocin

Interventions

  • DrugCarbetocin

    50 mcg or 100 mcg bolus of carbetocin

06

What researchers measure

Primary outcomes

  1. Tp-e

    Time interval between peak and end of T-wave (Tp-e)

    Time frame: 5 minutes post-carbetocin administration

Secondary outcomes

  1. Arrhythmia

    Occurrence of Atrial or Ventricular Arrhythmias

    Time frame: perioperatively, typically ranging 30 minutes-1 hour

  2. QTc at 5 Min

    Bazette corrected Q-T interval

    Time frame: 5 min post-carbetocin administration

  3. QTc 10 Min

    Bazette corrected Q-T interval (QTc)

    Time frame: 10 minutes post-carbetocin administration

  4. QTc 5 Min Spinal

    Bazette corrected Q-T interval change after spinal anesthesia

    Time frame: 5 min post-administration of spinal anesthesia

  5. Tp-e 5 Min Post-spinal

    Time between peak and end of T-wave,

    Time frame: 5 minutes after administration of spinal anesthesia

  6. Tp-e at 10 Min

    Time between peak and end of T-wave

    Time frame: 10 minutes post-carbetocin administration

07

Results

Posted May 14, 2021
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

Participant flow

Participant flow — Overall Study
MilestoneParticipant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.
Started2525
Completed2219
Not completed36

Outcome measures

PrimaryTp-e

Time interval between peak and end of T-wave (Tp-e)

Time frame:
5 minutes post-carbetocin administration
Reported as:
Mean · milliseconds
Tp-e
millisecondsParticipant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.
Tp-e69.5 ± 7.774.7 ± 4.7
Statistical analysis
  • Participant Receives 50 mcg of Carbetocin Post-delivery. vs Participant Receives 100 mcg of Carbetocin Post-delivery. ·
SecondaryArrhythmia

Occurrence of Atrial or Ventricular Arrhythmias

Time frame:
perioperatively, typically ranging 30 minutes-1 hour
Reported as:
Count of participants · Participants
Arrhythmia
ParticipantsParticipant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.
Arrhythmia00
SecondaryQTc at 5 Min

Bazette corrected Q-T interval

Time frame:
5 min post-carbetocin administration
Reported as:
Mean · milliseconds
QTc at 5 Min
millisecondsParticipant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.
QTc at 5 Min435.1 ± 18.3434.2 ± 18.8
SecondaryQTc 10 Min

Bazette corrected Q-T interval (QTc)

Time frame:
10 minutes post-carbetocin administration
Reported as:
Mean · milliseconds
QTc 10 Min
millisecondsParticipant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.
QTc 10 Min431.6 ± 18.2431.9 ± 15.4
SecondaryQTc 5 Min Spinal

Bazette corrected Q-T interval change after spinal anesthesia

Time frame:
5 min post-administration of spinal anesthesia
Reported as:
Mean · milliseconds
QTc 5 Min Spinal
millisecondsParticipant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.
QTc 5 Min Spinal409.4 ± 19.2413.6 ± 17.4
SecondaryTp-e 5 Min Post-spinal

Time between peak and end of T-wave,

Time frame:
5 minutes after administration of spinal anesthesia
Reported as:
Mean · milliseconds
Tp-e 5 Min Post-spinal
millisecondsParticipant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.
Tp-e 5 Min Post-spinal69.5 ± 8.670.9 ± 6.5
SecondaryTp-e at 10 Min

Time between peak and end of T-wave

Time frame:
10 minutes post-carbetocin administration
Reported as:
Mean · milliseconds
Tp-e at 10 Min
millisecondsParticipant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.
Tp-e at 10 Min69.4 ± 8.271.8 ± 5.5

Adverse events

Collected over 2 days, which is the typical time spent in hospital for monitoring after cesarean sections. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Participant Receives 50 mcg of Carbetocin Post-delivery.0/25 (0%)0/25 (0%)0/25 (0%)
Participant Receives 100 mcg of Carbetocin Post-delivery.0/25 (0%)0/25 (0%)0/25 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Participant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.Total
Mean34.5 ± 4.335.7 ± 2.835 ± 3.7
Sex: Female, Male
Sex: Female, Male(Participants)Participant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.Total
Female221941
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Participant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.Total
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Participant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.Total
Canada221941
Mean Arterial Pressure
Mean Arterial Pressure(mmHg)Participant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.Total
Mean89.7 ± 10.488.5 ± 8.389.2 ± 9.4
Heart Rate
Heart Rate(bpm)Participant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.Total
Mean83.0 ± 8.681.8 ± 9.082.0 ± 8.7
Gravida
Gravida(pregnancies)Participant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.Total
Median2 (2 to 3)2 (2 to 3)2 (2 to 3)
Parity of 0
Parity of 0(participants)Participant Receives 50 mcg of Carbetocin Post-delivery.Participant Receives 100 mcg of Carbetocin Post-delivery.Total
Number7512

6 further baseline measures are reported on the registry.

08

Study locations

1 site
  • BC Women's Hospital
    Vancouver, British Columbia V6H 3N1, Canada
09

References and documents

Publications

  • 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. PubMed 32149759 ↗

Study documents

  • Study protocol · Sep 26, 2019
  • Statistical analysis plan · Sep 26, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03716076
Lead sponsor
University of British Columbia
Responsible party
Anthony Chau (Clinical Assistant Professor, University of British Columbia) — Principal investigator
First posted
Oct 23, 2018
Start date
Nov 1, 2018
Primary completion
Jun 15, 2019
Completion
Apr 24, 2020
Results posted
May 14, 2021
Last update
May 14, 2021

Study contacts

Anton Chau, MD MMSc
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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