Investigating the Effect of Pulsatile Administration of Oxytocin on the Desensitization of Human Myometrium 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 (myometrium) tone after delivery.

It had three arms (groups): Control (no oxytocin) pretreatment (no intervention), Continuous oxytocin (desensitizing) pretreatment (active comparator) and Pulsatile oxytocin pretreatment (active comparator).

Physiological saline solution (PSS). Every 15-minutes, the PSS will be flushed and fresh PSS will be added.

15-minutes of 10-5M oxytocin, followed by PSS for 15-minutes, followed by 10-5M oxytocin, followed by 15-minutes PSS, and so-on, for a total duration of two-hours,.

The registry classes the interventions as drug.

More on the Plan

Typically labor can be augmented by exposure to high levels of continuous oxytocin, for prolonged periods.

However, the outcome of the effect on PPH is not currently known.

Characterization of the effect of pulsatile oxytocin on the desensitization of myometrium when compared to the effect of continuous oxytocin, may provide guidance for the delivery of pulsatile oxytocin for labor induction and augmentation to protect against the otherwise higher risk of PPH.

Furthermore, the delivery of pulsatile oxytocin may be considered in subgroups who are already at higher risk of PPH, and require labor augmentation.

Who Took Part

Enrollment: 18 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.

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

It started in 2015-01 with completion listed for 2015-06.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was 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 18 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.