Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

What Was Tested

The trial (phase 4) is built around Oxytocin.

To evaluate the effects of oxytocin infusion during abdominal myomectomy.

It had two arms (groups): Oxytocin infusion (experimental) and Placebo (placebo comparator).

Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia.

Patients will receive pure normal saline infusion at the same rate and volume just before the surgery after the induction of general anesthesia.

The registry classes the interventions as drug and other.

More on the Plan

Myomectomy is indicated for symptomatic uterine fibroids.

Who Took Part

The registry lists 100 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Patients who are candidate for abdominal myomectomy.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: history of previous myomectomy; suspected malignancy; patients with preoperative anemia.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and investigator.

It started in 2017-10-01 with completion listed for 2018-05-10.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Blood loss during surgery (time frame: 2 hours).

It also tracked 1 secondary outcome, for example Blood loss after abdominal myomectomy.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 100 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.