Effect of Magnesium Sulphate Pre-exposure on Oxytocin-induced Contractility in Desensitized Human Myometrium - an in Vitro Study

What Was Tested

This registered not phased trial tested Oxytocin.

It is a major cause of maternal morbidity and mortality across the globe.

Oxytocin is a naturally-occurring hormone that causes the uterus to contract, thereby causing labor.

It had three arms (groups): Control (no oxytocin) pretreatment (no intervention), Magnesium Sulphate (active comparator) and Magnesium Sulphate + oxytocin (active comparator).

The myometrial samples are bathed in physiological saline solution (PSS).

The myometrial samples are bathed in a 3.5mM magnesium sulphate solution.

The myometrial samples are bathed in a 3.5mM magnesium sulphate plus 10-5M oxytocin solution.

The registry classes the interventions as drug.

More on the Plan

There is evidence that patients with preeclampsia already have a higher risk of PPH than non-preeclamptic patients.

In the presence of the effects of MgSO4 treatment on the uterus, PPH could be worse in theory.

If patients have had oxytocin-augmented labor, then the desensitization effect on the uterus also comes into play.

Performing this study in vitro will allow them to assess the effects on the uterine muscle of MgSO4 in oxytocin-desensitized tissue samples.

Who Took Part

Enrollment: 26 actual participants took part.

It was open to women only aged from 16 years up to 40 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 delivery or first repeat Cesarean delivery under spinal anesthesia.

The full record lists 4 inclusion and 6 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 delivery.

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 2016-01 with completion listed for 2017-04.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Motility Index (time frame: 2 hours).

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

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Oxytocin in 26 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.