EMG for Uterotonic Efficiency Estimation

What Was Tested

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

The investigators are planning a single-center, randomized, open-label trial to compare uterine EMG parameters in women receiving oxytocin vs. those receiving carbetocin after cesarean delivery.

It had two arms (groups): carbetocin (experimental) and oxytocin (active comparator).

The registry classes the interventions as drug.

More on the Plan

RATIONALE Postpartum hemorrhage is the leading cause of maternal mortality worldwide.

In the Western world the estimated risk of life threatening postpartum hemorrhage is 2 on 1000 births.

Carbetocin is a synthetic heat-stable analogue of oxytocin, with a longer half-life.

It shares the same mechanism of action and the same side-effects as oxytocin.

Who Took Part

The registry lists 60 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with singleton pregnancies at term ( ≥37 weeks of pregnancy) scheduled for elective cesarean section after one previous cesarean section.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: contraindications for any of the study drugs; history of postpartum hemorrhage; uterine fibroids.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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 2020-09-13 with completion listed for 2022-01-31.

It ran at 1 site in Slovenia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Power density spectrum peak frequency of uterine EMG bursts (time frame: within 3 hours from starting treatments).

It also tracked 7 secondary outcomes, for example Power density spectrum peak amplitude of uterine EMG bursts, Frequency and duration of uterine EMG bursts, Propagation velocity of uterine EMG signals, Power density spectrum integral of uterine EMG bursts, Change in hematocrit and Change in hemoglobin.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 60 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 and the Carbetocin compound page, all human trials.