Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy

What Was Tested

This registered phase 4 trial tested Carbetocin.

Submucous myomas represent one of the main indications of operative hysteroscopy.

Hysteroscopic myomectomy is currently considered the "gold standard" minimally invasive approach for the treatment of symptomatic submucous myomas .

It had two arms (groups): Carbetocin group (experimental) and • Control group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

All patients will have preoperative evaluation by gynecologists and anesthetists, with history taking and pelvic examination.

Prior office diagnostic hysteroscopy will be performed for evaluation of the number, location and grade of the submucous myomas, and assessment of the endocervical canal and uterine cavity and the position of the tubal ostia in order to aid orientation.

Preoperative full blood count, serum creatinine, fasting blood glucose, liver enzymes, coagulation profile ( INR), and viral markers will be done for all the patients.

Monopolar resectoscopic myomectomies will be scheduled in the proliferative phase of menstrual cycle by a single experienced operator.

Who Took Part

40 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: • age \< 18 or \> 45 years; uterine septum or structural uterine abnormality (including multiple uterine fibroids and/or multiple submucous myomas); present or history of cervical or uterine malignancies.

How the Study Was Run

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

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

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, care provider and investigator.

It started in 2020-07-15 with completion listed for 2021-12-30.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: intraoperative bleeding amount. • Change in haemoglobin and hematocrit (time frame: Haemoglobin and hematocrit values 24 hours before myomectomy and 24 hour after myomectomy).

It also tracked 3 secondary outcomes, for example • Operative time, • Fluid deficit and • The quality of operative view.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Carbetocin in 40 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.