Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.

What Was Tested

This registered phase 2, phase 3 trial tested Vasopressin.

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

20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy.

The registry classes the interventions as drug.

More on the Plan

This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .

Who Took Part

Enrollment: 40 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy. Grade 0 and grade 1 submucous myomas. Less than 5 centimeters in diameter.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: patients with grade 2 submucous myoma or more; patients with submucous myomas larger than 5 cm in diameter; postmenopausal women.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Vasopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Only one side, usually the participants, was kept unaware of whether Vasopressin was given.

Those kept unaware of assignments: participant.

It started in 2016-05-02 with completion listed for 2017-01-30.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: intraoperative bleeding. operative time. haemoglobin and hematocrit deficit (time frame: 24 hours before myomectomy and 24 hour after myomectomy).

It also tracked 3 secondary outcomes, for example Degree of visual clarity, Fluid deficit and time need for cervical dilatation.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Vasopressin in 40 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.