Spontaneous and Oxytocin-induced Contractility After Exposure to Intravenous Anesthetic Agents: an In-vitro Study in Human Myometrium

What Was Tested

This registered not phased trial tested Oxytocin.

Poor uterine tone after the birth of a baby may cause serious bleeding (called postpartum hemorrhage or PPH).

It had six arms (groups): Ketamine (active comparator), Ketamine + oytocin (active comparator), Propofol (active comparator), Propofol + oytocin (active comparator) and Etomidate (active comparator).

The registry classes the interventions as drug.

More on the Plan

This will be the first study that compares the three commonly used intravenous anesthesia agents on human myometrium: ketamine, etomidate and propofol.

This study is required to allow doctors make informed decisions about which anesthesia agent is most suitable to manage their patient depending on clinical circumstances.

The investigators will study both spontaneous and oxytocin induced contractility.

Who Took Part

33 actual participants took part.

It was open to women only aged from 19 years up to 50 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. Patients of 19-50 years. Non-laboring patients, not exposed to exogenous oxytocin. Patients requiring primary Cesarean section or first repeat Cesarean section.

The full record lists 6 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.

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 2019-03-28 with completion listed for 2022-01-19.

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 33 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.