Carbetocin Myocardium Trial 2014 Part 2

What Was Tested

The trial (phase 4) is built around Oxytocin and Carbetocin.

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

The registry classes the interventions as drug.

More on the Plan

Background -Treatment Caesarean delivery is a commonly performed surgical procedure.

Uterus contraction after delivery of the baby is necessary to avoid excessive bleeding.

Background - Therapeutic Information Adequate uterus contraction after delivery of the baby is necessary to avoid excessive bleeding.

Prophylactic administration of an oxytocin receptor agonist is first line practice.

Who Took Part

Enrollment: 240 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Healthy pregnant women age 18 to 50. Singleton pregnancy at gestational age 36 weeks or more. Able to read and understand Norwegian.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: patients with placenta pathology such as praevia, accreta, pre-eclampsia; patients with bleeding disorders including vonwillebrand disease type i; known intolerance to one of the two drugs.

How the Study Was Run

The set-up was 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.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2019-04-02 with completion listed for 2022-03-01.

It ran at 2 sites in Norway (2).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Plasma Concentration Troponin I (time frame: 8 hours).

It also tracked 3 secondary outcomes, for example Blood Loss, Uterine Tone Grade and Side Effects.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin and Carbetocin in 240 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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