Carbetocin at Elective Cesarean Delivery Part 2

What Was Tested

The trial (not phased) is built around Carbetocin.

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

It had five 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.

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

120 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: All patients planned for elective cesarean delivery under spinal anesthesia. All patients who give written informed consent to participate in this study.

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

How the Study Was Run

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

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.

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

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 2011-06 with completion listed for 2011-12.

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, randomized trial of Carbetocin in 120 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.