Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy

What Was Tested

The trial (phase 4) is built around Vasopressin.

It had 1 arm (groups): Misoprostol + vasopressin, Vasopressin (experimental).

The registry classes the interventions as drug.

More on the Plan

A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus.

Twenty five patients received misoprostol and twenty patients did not.

Who Took Part

The registry lists 45 actual participants took part.

It was open to women only aged from 25 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients with symptomatic fibroids who desire future fertility and or who wish to maintain their uterus.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: patients who have had previous myomectomy or previous pelvic surgery; patients who refuse to participate or give consent to the procedures. patients with a known allergy to any of the study drugs.

How the Study Was Run

Design: single-group and double-blind.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and care provider.

It started in 2005-02 with completion listed for 2005-04.

It ran at 1 site in Jamaica.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Blood loss in millilitres (time frame: At the time of surgery).

It also tracked 1 secondary outcome, for example A change in hemoglobin grams per decilitre.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Vasopressin in 45 people.

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

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