Methods Decreasing Bleeding in Open Myomectomy

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin and Vasopressin.

Uterine leiomyomas (fibroids or myomas) are benign, smooth muscle tumors of the human uterus.

It had seven arms (groups): misoprostol (active comparator), Tourniquet (active comparator), Carbetocin (active comparator), Oxytocin (active comparator) and combined TXA and ethamsylate (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

Study Period: 6 months from April 2023 to October 2023.

The solution will be prepared just before the procedure.

Before each infiltration, aspiration will be performed to avoid intravascular injection.

The operations will be performed by the same team to avoid any bias related to surgical skills.

Who Took Part

Enrollment: 105 planned participants were the target.

It was open to women only aged from 25 years up to 48 years.

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

Examples of who could join: Patients aged between 25 to 48 years old. BMI less than 35 kg/m2. Symptomatic uterine myomas.. Myoma staging from (3 to 6) according to FIGO staging through trans vaginal ultrasonography (TVUSG) or magnetic resonance imaging (MRI) according to FIGO classification. Maximum diameter of the largest myoma is 15 cm.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: history of previous myomectomy; allergy to misoprostol, carbetocin, txa, ethamsylate, oxytocin, vasopressin, bupivacaine and epinephrine; cardiac and pulmonary diseases.

How the Study Was Run

The set-up was randomized, parallel-group and double-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.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2023-03-15 with completion listed for 2023-10-30.

It ran at 1 site in Egypt.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): blood loss (time frame: 3 hours).

It also tracked 5 secondary outcomes, for example blood transfusion, Preoperative and postoperative hemoglobin values, Perioperative blood pressure, the duration of hospital stays and Operation time.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin and Vasopressin in 105 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 Vasopressin compound page, all human trials.