Intravenous Oxytocin Versus Tranexamic Acid in Reducing Blood Loss During Abdominal Myomectomy.

What Was Tested

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

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

It had three arms (groups): tranexamic acid (experimental), oxytocin (active comparator) and placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The operations will be performed as standard through a midline or Pfannenstiel incision by the same consultant gynecologist to ensure consistency of study procedures.

All patients will receive general anesthesia.

After the skin incision, the subcutaneous fat and abdominal fascia will be opened crosswise, and the rectus muscle will be opened on the midline.

The parietal peritoneum will be opened longitudinally to reach the pelvic cavity.

Who Took Part

Enrollment: 150 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: • Age group (18-50) years old. Intramural or interstitial myomas (more than 5 cm). Symptomatic myomas (heavy menstrual bleeding or pain during menstruation). No medical disorders. No coagulation disorders.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: • age group (less than 18 yrs old); age group (more than 50 yrs old); subserous or submucous myomas.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

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

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

It started in 2019-04-30 with completion listed for 2020-02-01.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Intraoperative Blood loss (time frame: during the operation).

It also tracked 2 secondary outcomes, for example Operation time and Myomectomy time.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 150 people.

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

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