Oxytocin i.m./i.v. Versus Carbetocin i.v. in Elective Cesarean Sections

What Was Tested

This registered phase 4 trial tested Oxytocin and Carbetocin.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 550 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Elective cesarean section. Present informed consent. Completed 36 weeks of gestation.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: need for intubation (carbetocin is only licensed for epidural or spinal anesthesia); multiple fetus pregnancy; known coagulopathy.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-08-07 with completion listed for 2022-01-10.

It ran at 1 site in Switzerland.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): incidence of women with a delta hemoglobin ≥ [amount hidden]/l.

It also tracked 8 secondary outcomes, for example adverse maternal outcome parameters, adverse maternal outcome parameters, adverse maternal outcome parameters, adverse maternal outcome parameters, adverse maternal outcome parameters and adverse maternal outcome parameters.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin and Carbetocin in 550 people.

With 550 participants it is a large trial for this field.

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.