Carbetocin vs. Oxytocin: In-vitro Myometrial Contractions With and Without Oxytocin Pre-treatment

What Was Tested

The trial (not phased) is built around Oxytocin and Carbetocin.

The purpose of this study is to compare the ability of an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs.

Oxytocin is an old standard, but seems to suffer from a desensitization phenomenon.

It had two arms (groups): No drug pre-treatment (active comparator) and Drug pre-treatment (active comparator).

The registry classes the interventions as drug.

More on the Plan

Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity.

Patients participating in this study will be asked to donate a very small sample of uterine tissue during Cesarean section, which will be tested in the laboratory for the ability to contract in response to the uterotonics oxytocin and carbetocin.

The researchers will seek to better understand the effects of these drugs by comparing their contractile capability in isolated uterine tissue.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to women only.

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

Examples of who could join: Gestational age 37-41 weeks. Non-laboring patients, not exposed to exogenous oxytocin. Patients requiring primary or first repeat Cesarean section. Cesarean section under spinal anesthesia.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: patients who require general anesthesia; patient who had previous myometrial surgery or more than one previous cesarean section; patients with placental anomalies.

How the Study Was Run

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

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

Being open-label, the Oxytocin study did not mask who received what.

It started in 2010-01 with completion listed for 2012-03.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Amplitude of contraction (time frame: 6-8 hours).

It also tracked 3 secondary outcomes, for example Integrated area under response curve (AUC), Basal tone and Frequency of contraction.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Oxytocin and Carbetocin in 20 people.

Its size is small, so on its own it can only give an early look.

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.