In Vitro Optimization of Oxytocin-induced Myometrial Contractility by Propranolol

What Was Tested

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

The rates of cesarean deliveries (CD) and postpartum hemorrhage (PPH) are on the rise, with failed induction and augmentation of labor as major contributing factors.

Oxytocin is commonly used for labor induction, as well as during the third stage of labor to minimize the risk of primary PPH.

It had six arms (groups): one (active comparator), Propranolol (active comparator), one (active comparator), one (active comparator) and one (active comparator).

The myometrial samples are bathed in a propranol solution at 10 -6M.

The registry classes the interventions as drug.

More on the Plan

The tissue will also be frozen at the end of the experiment, and Western blotting will be used to investigate the effect of propranolol on the expression patterns and cellular distribution of the oxytocin receptor and beta-adrenergic receptor and their signaling pathways in desensitized myometrium.

Who Took Part

57 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.

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.

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 2017-09-08 with completion listed for 2022-08-19.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Motility index (time frame: 3 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 57 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.