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Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study
Plain-language guide to NCT03716076: phase 4 randomized trial of Carbetocin, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03716076
- Phase
- phase 4
- Status
- completed
- Start
- 2018-11-01
- Completion (planned or actual)
- 2019-06-15
- Participants
- 50 (actual)
- Design
- randomized, double-blind, diagnostic
- Conditions studied
- Cardiac Arrythmias
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Carbetocin.
It had two arms (groups): one (experimental) and one (experimental).
The registry classes the interventions as drug.
More on the Plan
The investigators aim to determine its effect on myocardial repolarization dynamics.
Who Took Part
The registry lists 50 actual participants took part.
It was open to women only aged from 19 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial anesthesia. American Society of Anesthesiologists (ASA) class 2. Patients ≥ 19 years of age.
The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: long qt syndrome; cardiac disease or rhythm abnormalities; family history of long qt syndrome or abnormal cardiac conduction.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
Because people in this Carbetocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Carbetocin group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Carbetocin.
Those kept unaware of assignments: participant and outcomes assessor.
It started in 2018-11-01 with completion listed for 2019-06-15.
It ran at 1 site in Canada.
Its stated primary purpose is diagnostic.
What Was Measured
Researchers chose this as the main measure: Tp-e (time frame: 5 minutes post-carbetocin administration).
It also tracked 6 secondary outcomes, for example Arrhythmia, QTc at 5 Min, QTc 10 Min, QTc 5 Min Spinal, Tp-e 5 Min Post-spinal and Tp-e at 10 Min.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Carbetocin in 50 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Carbetocin compound page, all human trials.
Our Notes on the Compound
Carbetocin: A long-acting oxytocin analog used outside the US to prevent bleeding after childbirth; also studied intranasally in Prader-Willi syndrome.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.