Phase 4
N=50
Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study
Cardiac Arrythmias
Bottom Line
View on ClinicalTrials.gov: NCT03716076 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Tp-e — 69.5; 74.7 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Carbetocin (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- University of British Columbia
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tp-e |
69.5; 74.7 | — |
| SECONDARY Arrhythmia |
0; 0 | — |
| SECONDARY QTc at 5 Min |
435.1; 434.2 | — |
| SECONDARY QTc 10 Min |
431.6; 431.9 | — |
| SECONDARY QTc 5 Min Spinal |
409.4; 413.6 | — |
| SECONDARY Tp-e 5 Min Post-spinal |
69.5; 70.9 | — |
| SECONDARY Tp-e at 10 Min |
69.4; 71.8 | — |
Summary
Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03716076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.