Methods to Reduce Blood Loss in Abdominal Myomectomy

What Was Tested

This registered phase 4 trial tested Oxytocin and Carbetocin.

It had four arms (groups): Misoprostol group (active comparator), Oxytocin group (active comparator), Carbetocin group (experimental) and pericervical tourniquet group (active comparator).

The registry classes the interventions as drug and procedure.

More on the Plan

Uterine leiomyomas (fibroids) are the most common benign tumours among women.

Surgery is indicated for symptomatic uterine leiomyomas; hysterectomy for women who have completed childbearing (women \> 40 years old), and myomectomy for women \<40 years old who wish to preserve uterine and fertility .Myomectomy can be accomplished by laparotomy, laparoscopy, or hysteroscopy (transvaginal) approaches.

Medical agents are always an attractive option to arrest haemorrhage.

Preoperative Misoprostol, a prostaglandin E1 analogue, was registered in many countries for use in gynaecology and obstetrics.

Who Took Part

The registry lists 120 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: Age between 20-40 years. 1-5 symptomatic intramural, submucous or subserous myomas by ultrasound. Mean uterine fibroid size of 5-10 cm. Presented with abnormal uterine bleeding, dull lower abdominal pain, infertility or recurrent miscarriage and are candidates for abdominal myomectomy.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: history of previous abdominal or pelvic surgery (laparotomy) except cesarian section; history of pelvic or ovarian endometriosis; history of pid.

How the Study Was Run

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

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

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

Only one side, usually the participants, was kept unaware of whether Oxytocin was given.

Those kept unaware of assignments: participant.

It started in 2020-11-01 with completion listed for 2022-08-31.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Intraoperative blood loss (time frame: baseline).

It also tracked 7 secondary outcomes, for example The need for blood transfusion, Preoperative and postoperative haemoglobin and haematocrit values, Perioperative blood pressure and HR, Time of ambulation, Post-operative hospital stay and Operation time.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin and Carbetocin in 120 people.

Its status is unknown; 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.