Evaluating Efficacy of Intravenous Carbetocin Versus Intramyometrial Injection of Adrenaline in Reducing Blood Loss

What Was Tested

This registered phase 1 trial tested Carbetocin.

Although most are asymptomatic, fibroids can often cause abnormal uterine bleeding, iron deficiency anemia, pelvic pressure symptoms and pain.

It had two arms (groups): Group A (active comparator) and Group B (experimental).

The registry classes the interventions as drug.

More on the Plan

The excessive bleeding may result in blood transfusions and prolonged hospital stays.

Currently, there are several strategies for the treatment of fibroids.

Still, myomectomy, the surgical removal of myomas, is an important treatment option for symptomatic leiomyomas, especially in women who wish to preserve their uteri.This can be accomplished via laparotomy, laparoscopy or hysteroscopy.

Oxytocin is a hormone secreted from the posterior pituitary and exerts its effect on the uterus by producing uterine contractions during labor and delivery.

Who Took Part

The registry lists 62 actual participants took part.

It was open to women only aged from 25 months up to 50 years.

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

Examples of who could join: Women aged 25-50 years old.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: women with previous myomectomy; pregnant and postmenopausal women; women who are candidate for and choosing vaginal or laparoscopic myomectomy.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Carbetocin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2023-02-01 with completion listed for 2023-08-30.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Side Effects Of the used drugs in the operation.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Carbetocin in 62 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carbetocin compound page, all human trials.