the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy

What Was Tested

This registered phase 4 trial tested Carbetocin.

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

10 cm syringe normal saline IV given just before skin incision of myomectomy.

The registry classes the interventions as drug.

Who Took Part

The registry lists 138 actual participants took part.

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

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

Examples of who could join: • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging. Age ≥ 25 years and ≤ 50 years. Ability to understand and the willingness to sign a written informed consent. Admissible medical/surgical history. Five or less symptomatic uterine myomas.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: • post-menopausal women; patients with known bleeding/clotting disorders; patients with a history of gynecologic malignancy.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Carbetocin and who got the comparison, which limits bias.

The Carbetocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Carbetocin, so expectations could not easily colour the readings.

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

It started in 2019-09-10 with completion listed for 2020-02-10.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Mean amount of intraoperative blood loss (time frame: intraoperative).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Carbetocin in 138 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.