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Intravenous Tranexamic Acid Versus IV Carbetocin in Abdominal Myomectomy
Plain-language guide to NCT04357015: phase 4 randomized trial of Carbetocin, 153 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04357015
- Phase
- phase 4
- Status
- status unknown
- Start
- 2020-05-01
- Completion (planned or actual)
- 2020-10-10
- Participants
- 153 (estimated)
- Design
- randomized, quadruple-blind, prevention
- Conditions studied
- Myomectomy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Carbetocin.
It had three arms (groups): intravenous tranexamic acid (experimental), intravenous carbetocin (active comparator) and placebo (placebo comparator).
The placebo group will be given a normal saline IV bolus 20 minutes before surgical incision.
The registry classes the interventions as drug.
Who Took Part
The registry lists 153 planned participants were the target.
It was open to women only.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Women with symptomatic fibroids candidate for abdominal myomectomy with staging of myoma from (3 to 6) according to FIGO staging.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: women with myoma figo staging (1,2,7 and 8) candidate for laparoscopic or hysteroscopic myomectomy, women with allergy or contraindications to carbetocin or tranexamic acid.
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
The participants were allocated by chance, so the Carbetocin group and the comparison group should start out alike.
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, care provider, investigator and outcomes assessor.
It started in 2020-05-01 with completion listed for 2020-10-10.
Its stated primary purpose is prevention.
What Was Measured
Researchers chose this as the main measure: intraoperative blood loss (time frame: one hour).
It also tracked 1 secondary outcome, for example need for blood transfusion.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Carbetocin in 153 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
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.