Carbetocin at Elective Cesarean Delivery Part 4

What Was Tested

The trial (not phased) is built around Carbetocin.

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

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 110 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 delivery under spinal anesthesia. Written informed consent to participate in this study.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: refusal to give written informed consent; allergy or hypersensitivity to carbetocin or oxytocin; 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.

The Carbetocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Carbetocin, so expectations could not easily colour the readings.

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

It started in 2014-10 with completion listed for 2015-04.

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 4 secondary outcomes, for example Uterine tone, Additional uterotonic medication administration, Blood loss and Side Effects.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carbetocin in 110 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.