Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy

What Was Tested

The trial (not phased) is built around Oxytocin.

There is no previous study on the hemostatic effect of intrauterine instillation of oxytocin in hysteroscopic myomectomy.

All previous studies focused on intravenous administration of oxytocin.

It had two arms (groups): Group A (Oxytocin group): (active comparator) and Group B (Placebo group): (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Patients will be subjected to: 1.

History taking: including personal history, menstrual and obstetric history, medical and surgical history, medications. 2.

Clinical examination; General and local with special concern about: 1.

Size and position of the uterus 2.

Who Took Part

60 actual participants took part.

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

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

Examples of who could join: Symptomatic patient (Menorrhagia, recurrent pregnancy loss or infertility). 1 or 2 submucous uterine myoma diagnosed by ultrasound with a diameter less than 4 cm. Myoma with FIGO 0 or 1. Body mass index less than 35.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: active pelvic infection; history of bleeding disorder or patient on anti-coagulant; hepatic and renal diseases.

How the Study Was Run

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

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, care provider and investigator.

It started in 2021-04-15 with completion listed for 2022-07-01.

It ran at 1 site in Egypt.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: the change in hemoglobin level 24 hours after the procedure surgery (time frame: preoperative and 24 hour postoperative). the change of hematocrit level 24 hour after the procedure (time frame: preoperative and 24 hour postoperative).

It also tracked 5 secondary outcomes, for example the surgeon rating of intraoperative bleeding and the visual field quality of operative view,, the duration of surgery, intraoperative, intraoperative and postoperative complications, the surgeon rating the visual field and the volume of distension media used intraoperative.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 60 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.