Cardiovascular Effects of Carbetocin Given During Elective Cesarean

What Was Tested

The trial (phase 4) is built around Carbetocin.

The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing.

It had two arms (groups): Infusion (experimental) and Bolus (active comparator).

Carbetocin is given slowly.

Carbetocin is given quickly.

The registry classes the interventions as drug.

More on the Plan

Patients undergoing elective cesarean under spinal are included in the study.

The study is a randomised double blind controlled trial with 2 groups.

One group will receive carbetocin quickly, the second group will receive carbetocin slowly.

The investigators will compare the difference between groups with respect to side effects and the effect of carbetocin on the cardiovascular system.

Who Took Part

Enrollment: 57 actual participants took part.

It was open to women only aged from 19 years with no upper age limit.

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

Examples of who could join: Elective cesarean delivery under spinal,. Low risk for post partum hemorrhage,. Able to understand english.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: cesarean under general anesthesia,; bleeding condition,; placenta previa,.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Carbetocin and who got the comparison, which limits bias.

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 and investigator.

It started in 2016-03 with completion listed for 2016-06.

It ran at 1 site in Canada.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): percent change in cardiac output parameters as measured by non-invasive cardiac output monitor (time frame: 10 minutes).

It also tracked 1 secondary outcome, for example incidence of side effects occurring within timeframe below.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Carbetocin in 57 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.