Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial

What Was Tested

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

The first reported study of the use of a vasoconstrictive agent for this purpose was on the use of epinephrine injected intracervically preoperatively by England, et. al.

It had two arms (groups): No injection (no intervention) and Injection of vasopressin (experimental).

Patients did not receive an injection at cervix prior to beginning the procedure.

The registry classes the interventions as drug.

Who Took Part

58 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Women greater that 18 undergoing vaginal hysterectomy for any indication, with or without concomitant procedures.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

The set-up was 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.

In this single-blind Vasopressin study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2004-01 with completion listed for 2005-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Intra-operative Blood Loss During Vaginal Hysterectomy (time frame: Blood loss will be assessed at the end of the operative procedure). Estimated Blood Loss (time frame: Duration of vaginal hysterectomy).

It also tracked 1 secondary outcome, for example Operative Time and Complication Rates.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vasopressin in 58 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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