Recovery of Oxytocin Responsiveness in Pregnant Human Myometrial Explants After Oxytocin-Induced Desensitization

What Was Tested

This registered not phased trial tested Oxytocin.

Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide and is caused most commonly by poor uterine muscle tone after delivery.

It had two arms (groups): Control (no intervention) and Oxytocin (experimental).

A control sample from each patient (no oxytocin applied) will be measured concurrently with samples treated with oxytocin.

Samples from each patient will be exposed to oxytocin and then allowed to rest for 30, 60 or 90 minutes.

The registry classes the interventions as drug.

More on the Plan

The investigators have previously established an in vitro model of labour augmentation and myometrial desensitization using pregnant human myometrium and an isometric tension recording device.

The investigators propose to use this model in order to characterize the time course of recovery of oxytocin-desensitized myometrium to oxytocin sensitivity.

These results will help in establishing whether myometrial recovery can occur within a clinically relevant time period, how much sensitivity is recovered, and the duration required.

The results of this study will provide insight into the time course of recovery of the myometrium using an in vitro model of failed labour augmentation.

Who Took Part

The registry lists 22 actual participants took part.

It was open to women only aged from 18 years up to 55 years.

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

Examples of who could join: Patients who give written consent to participate in this study. Patients with gestational age 37-41 weeks. Non-laboring patients, not exposed to exogenous oxytocin. Patients requiring primary Cesarean section or first repeat Cesarean section.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: patients who refuse to give written informed consent; patients who require general anesthesia; patients who had previous uterine surgery or more than one previous cesarean section.

How the Study Was Run

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

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

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-12 with completion listed for 2014-06.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Amplitude of contraction (time frame: 2-4 hours).

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

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Oxytocin in 22 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, all human trials.