The Clinical Carbetocin Myocardium Trial

What Was Tested

The trial (phase 4) is built around Oxytocin and Carbetocin.

Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.

It had two arms (groups): Carbetocin (experimental) and Oxytocin (active comparator).

The registry classes the interventions as drug.

More on the Plan

There is no clinical study comparing the specific myocardial effects of oxytocin with carbetocin.

It may have great impact on the choice of standard medication if the cardiotoxicity of carbetocin is lower compared with oxytocin.

The study of potential cardiotoxicity has to be performed in healthy women.

Knowing that millions of laboring women have had uneventful injections of oxytocin and carbetocin after delivery, there is probably no reason to fear long lasting negative effects of either drug.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Healthy pregnant women age 18 to 50. Singleton pregnancy at gestational age 36 weeks or more. Able to read and understand Norwegian.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: patients with placenta pathology such as praevia, acreta, pre-eclampsia; patients with bleeding disorders including vonwillebrand disease type i; known intolerance to one of the two drugs.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin 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 Oxytocin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-09 with completion listed for 2019-01-28.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: P-Troponin I (time frame: 48 hours).

It also tracked 3 secondary outcomes, for example P-Biomarkers, ECG-changes and Blood loss.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin and Carbetocin in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page and the Carbetocin compound page, all human trials.