In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

Postpartum hemorrhage (PPH) remains to be one of the leading causes of maternal morbidity and mortality.

Myometrial contraction is affected by the choice of anesthetic technique and medications during cesarean delivery (CD).

It had six arms (groups): Dexmedetomidine (active comparator), Oxytocin (active comparator), Dexmedetomidine + Oxytocin (active comparator), Oxytocin pre-treatment followed by Dexmedetomidine (active comparator) and Oxytocin pre-treatment followed by Oxytocin (active comparator).

The myometrial samples are bathed in oxytocin 20nM.

The myometrial samples are bathed in oxytocin at 20nM along with dexmedetomidine (10-9M to 10-4M).

The registry classes the interventions as drug.

Who Took Part

The registry lists 50 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Pregnant patients scheduled for elective CD under regional anesthesia at 37-41 weeks of gestational age will be included in this study. Only patients for primary CD or repeat CD (1x) will be included in this study since excessive uterine scarring from multiple CD may affect the contractility of myometrial sample.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: patient refusal; emergency cd; general anesthesia.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

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 2022-11-02 with completion listed for 2024-11-21.

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: 4 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 50 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.