Carbetocin Versus Ergometrin in the Prevention of Postpartum Hemorrhage

What Was Tested

In this phase 4 trial, researchers set out to test Carbetocin.

As indicators will be used intraoperative blood loss, as well as the value of hemoglobin and hematocrit 24 hours after the caesarian section.

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

The registry classes the interventions as drug.

More on the Plan

It is a prospective comparative single blind randomized study which will be carried out in the G.N.M.A. "Elena Venizelou".

The sample will be constituted by parturients that will undergo Caesarean section.

The parturients will be divided in two groups: the group to which carbetocin will be administered and the group to which ergometrin will be used as the main uterotonic drug.

Randomization will be achieved with the help of a computer and the method ¨sealed envelope¨.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Female gender Gestating Between 18-40 years No co-morbidity.

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: exclusion criteria; under age parturients; parturients \>40 years of age.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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 and care provider.

It started in 2018-04-05 with completion listed for 2020-06-10.

It ran at 1 site in Greece.

Its stated primary purpose is prevention.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Carbetocin in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carbetocin compound page, all human trials.