In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity

What Was Tested

This registered not phased trial tested Oxytocin.

Women with advanced maternal age and morbid obesity, have a higher incidence of labor induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum hemorrhage (PPH).

Oxytocin is the first line drug in the treatment of PPH, however, oxytocin receptor (OTR) desensitization has been recognized in the context of prolonged labors secondary to either endogenous or exogenous oxytocin exposure.

It is unknown if oxytocin desensitization specifically affects contractility in women with advanced maternal age and morbid obesity when compared to younger or normal weight populations.

It had two arms (groups): Control (no intervention) and Oxytocin (experimental).

A control sample from each patient (no oxytocin applied) will be measured concurrently with samples treated with varying concentrations of oxytocin.

Samples from each patient will be bathed in a solution containing varying concentrations of oxytocin.

The registry classes the interventions as drug.

More on the Plan

In view of the growing concern over the rising incidence of later maternal age and morbid obesity in the obstetric population, scientific evidence on pregnancy outcomes in these patients is timely and important.

The investigators' previously validated in-vitro model provides a solid foundation for the study of myometrial contractility under controlled conditions, without any confounders that could be encountered in clinical settings.

It is also likely to provide in-depth understanding of the parameters that the investigators feel are responsible for higher incidence of PPH in these patients.

Who Took Part

The registry lists 44 actual participants took part.

It was open to women only.

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

Examples of who could join: Patients who give written informed consent. Patients requiring elective primary or 1st repeat Cesarean section. Patients with gestational age 37-41 weeks. Non-labouring patients, not exposed to exogenous oxytocin. Cesarean section under spinal anesthetic.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: patients who refuse to give written informed consent; patients who require general anesthesia; patients who have had more than one previous uterine surgery/cs.

How the Study Was Run

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

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 2013-05 with completion listed for 2017-06-13.

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: 6-8 hours).

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

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Oxytocin in 44 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.