DRUG
Carbetocin
50 mcg or 100 mcg bolus of carbetocin
Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study
Status
Completed
Phase
Phase 4
Enrollment
50
Locations
1
Results
Posted
Publications
1
Study summary
What the protocol is testing.
Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).
Full 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
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 23, 2018
Study start
Nov 1, 2018
Primary completion
Jun 15, 2019
Study completion
Apr 24, 2020
Results posted
May 14, 2021
Registry updated
May 14, 2021
Outcomes
What the study measures.
Primary outcomes
Tp-e
Time frame · 5 minutes post-carbetocin administration
Time interval between peak and end of T-wave (Tp-e)
Secondary outcomes
Arrhythmia
Time frame · perioperatively, typically ranging 30 minutes-1 hour
Occurrence of Atrial or Ventricular Arrhythmias
QTc at 5 Min
Time frame · 5 min post-carbetocin administration
Bazette corrected Q-T interval
QTc 10 Min
Time frame · 10 minutes post-carbetocin administration
Bazette corrected Q-T interval (QTc)
QTc 5 Min Spinal
Time frame · 5 min post-administration of spinal anesthesia
Bazette corrected Q-T interval change after spinal anesthesia
Tp-e 5 Min Post-spinal
Time frame · 5 minutes after administration of spinal anesthesia
Time between peak and end of T-wave,
Tp-e at 10 Min
Time frame · 10 minutes post-carbetocin administration
Time between peak and end of T-wave
Eligibility
Who can take part.
- Minimum age
- 19 Years
- Maximum age
- Not reported
- Sex
- FEMALE
- 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: * 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 locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
BC Women's Hospital
Vancouver, British Columbia, Canada
Related trials
More studies on Carbetocin.
NCT IDStudyPhase / statusEnrollmentUpdated
The Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy
Alex Ekwueme Federal University Teaching Hospital · Blood Loss, Surgical
Early Phase 1
Not yet recruiting
900
2026-07
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Mansoura University · Postpartum Hemorrhage · Uterine Atony
Phase 4
Not yet recruiting
332
2026-06
Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage
Sheba Medical Center · Postpartum Hemorrhage · Twin Pregnancy
Phase 4
Recruiting
120
2026-05
Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage
Not applicable
Recruiting
32
2026-04
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Post Partum Hemorrhage
Not applicable
Recruiting
160
2026-04
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Postpartum Hemorrhage (Primary)
Not applicable
Recruiting
120
2026-04
Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients
Ankara Etlik City Hospital · Postpartum Hemorrhage \(PPH\)
Not applicable
Completed
300
2026-02
Carbetocin Myocardium Trial 2014 Part 2
Oslo University Hospital · Pregnancy Complications
Phase 4
Completed
240
2026-02
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