Carbetocin at Elective Cesarean Delivery Part 3

What Was Tested

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

Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity.

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

The registry classes the interventions as drug.

More on the Plan

In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin.

This study will be conducted as a prospective, randomized, up-down sequential allocation trial.

It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at their institution as well as others.

Who Took Part

40 actual participants took part.

It was open to women only aged from 18 years up to 55 years.

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

Examples of who could join: Patients planned for elective cesarean delivery under spinal anesthesia. Patients who give written informed consent to participate.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: patients who refuse to give written informed consent; patients who claim allergy or hypersensitivity to carbetocin or oxytocin; patients with hepatic, renal, and vascular disease.

How the Study Was Run

It was run as a non-randomized, parallel-group and quadruple-blind study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Carbetocin 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 2012-06 with completion listed for 2012-08.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Uterine tone (time frame: 2 minutes).

It also tracked 3 secondary outcomes, for example Uterine tone, Blood loss and Side effects.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of 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 Carbetocin compound page, all human trials.