Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy

What Was Tested

The trial (phase 3) is built around Oxytocin.

Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old.

They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms.

Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus.

It had two arms (groups): misoprostol (active comparator) and oxytocin (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 56 planned participants were the target.

It was open to women only aged from 20 years up to 48 years.

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

The full record lists 0 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

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

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

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

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

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2024-03-01 with completion listed for 2024-12-01.

It ran at 1 site in Egypt.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: intra-operative blood loss (time frame: time of surgery).

It also tracked 3 secondary outcomes, for example blood transfusion, post-operative Hb and total surgery time.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 56 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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