Carbetocin vs. Oxytocin at Elective Cesarean Section

What Was Tested

In this not phased trial, researchers set out to test Oxytocin and Carbetocin.

It had four arms (groups): one (active comparator), one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

However, oxytocin has a very short duration of action, requiring a continuous infusion to achieve sustained uterotonic activity.

There is a lack of consensus as to what the optimal uterotonic regime is globally.

These advantages may provide a better safety profile and patient satisfaction.

Who Took Part

278 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Elective cesarean section under spinal anesthesia. Written informed consent to participate in this study. Non labouring patients.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: refusal to give written informed consent; allergy or hypersensitivity to carbetocin or oxytocin; labouring patients.

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.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2017-05-25 with completion listed for 2020-12-17.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Uterine Tone 2 minutes (time frame: 2 minutes).

It also tracked 18 secondary outcomes, for example Uterine Tone 5 minutes, Uterine Tone 10 minutes, Additional uterotonics - operating room, Additional uterotonics - 24 hours, Estimated blood loss and Presence of ventricular tachycardia: ECG.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 278 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.