Impact of Uterotonic Agents on Isolated Human Myometrium

What Was Tested

The trial (not phased) is built around Oxytocin.

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

It had two arms (groups): No treatment (no intervention) and Treatment (active comparator).

A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs.

Samples from each patient will be bathed in solutions containing varying concentrations of either oxytocin, carboprost and ergonovine, and contractility will be measured.

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 for the ability to contract after treatment with various uterotonic drugs (oxytocin, ergonovine and carboprost) in the laboratory.

This information will help them know the effect of these drugs by comparing the contractile capability of the uterine tissue.

Who Took Part

The registry lists 56 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 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 uterine surgery or cesarean section; patients with placental anomalies.

How the Study Was Run

The set-up was 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 2007-06 with completion listed for 2013-08.

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 in 56 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, all human trials.