Oxytocin vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity

What Was Tested

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

Carbetocin is currently recommended by the SOGC (Society of Obstetricans \& Gynecologists of Canada), and is a relatively newer drug with a longer duration of action.

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

The registry classes the interventions as drug.

More on the Plan

Obesity in pregnancy is defined as a Body Mass Index (BMI) above 30 kg/m2 and is often cited as a risk factor for PPH after cesarean delivery.

While oxytocin is the most commonly used drug world-wide, multiple agents are available and there is no clear consensus as to which drug should be first choice.

Who Took Part

48 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, epidural, or combined spinal-epidural anaesthesia. Written informed consent. Full term pregnancy (37+0 to 40+6 weeks gestation).

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: refusal to give written informed consent; allergy or hypersensitivity to carbetocin or oxytocin; laboring patients.

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

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

It started in 2021-07-20 with completion listed for 2022-12-08.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Uterine Tone 3 minutes (time frame: 3 minutes).

It also tracked 20 secondary outcomes, for example Uterine Tone 5 minutes, Uterine Tone 10 minutes, Additional uterotonics - operating room, Additional uterotonics - Post Anesthesia Care Unit (PACU), Additional uterotonics - 24 hours and Estimated blood loss calculated.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 48 people.

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.