Investigating the Effect of Extracellular Calcium on Oxytocin-induced Human Myometrial Contractility In-vitro

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 six arms (groups): 1.25mM Calcium-NO oxytocin pretreatment (active comparator), 2.5mM Calcium-NO oxytocin pretreatment (active comparator), 5.0mM Calcium-NO oxytocin pretreatment (active comparator), 1.25mM Calcium-WITH oxytocin pretreatment (active comparator) and 2.5mM Calcium-WITH oxytocin pretreatment (active comparator).

The registry classes the interventions as drug.

More on the Plan

Calcium is an important messenger required within the uterine muscle cell to result in muscle contraction following administration of oxytocin.

A physiological level of calcium is known to provide optimal contractility to normal myometrium.

Characterization of the importance of low, normal or high calcium levels in a setting of prolonged exogenous oxytocin administration may provide guidance for the use of exogenous calcium as a uterotonic adjunct; or for the optimization of serum calcium levels during augmented labor.

In the clinical setting of failed labor augmentation and OTR desensitization, the role of serum calcium levels is not currently known.

Who Took Part

41 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 CD or first repeat CD.

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 cd.

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.

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 2014-11 with completion listed for 2015-03.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Motility Index (time frame: 8 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 41 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.