The Effect of Intramyometrial Injection of Terlipressin Versus Intramyometrial Injection of Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations

What Was Tested

This registered not phased trial tested Terlipressin.

It had three arms (groups): intramyometrial Terlipressin (active comparator), intramyometrial carbitocin (active comparator) and intramyometrial saline (placebo comparator).

Intramyometrial injection of Terlipressin in women undergoing laparoscopic myomectomy procedure.

Intramyometrial injection of Carbetocin in women undergoing laparoscopic myomectomy procedure.

Intramyometrial injection of saline in women undergoing laparoscopic myomectomy procedure.

The registry classes the interventions as drug.

More on the Plan

Fibroids are firm benign tumors that are made of smooth muscle cells and fibrous connective tissue.

However, their true prevalence is probably underestimated .

However, bleeding is often a problem in a myomectomy and can result in intra-operative hypovolaemic shock, post-operative anemia, and delayed recovery .

The current treatments for uterine fibroids are many, medical as progesterone's and progesterone antagonist's, surgical, and recent myoma therapies as uterine artery embolization, but surgical resection is still the main treatment, including hysterectomy and myomectomy.

Who Took Part

The registry lists 99 planned participants were the target.

It was open to women only aged from 16 years up to 45 years.

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

Examples of who could join: Women aged 16-45 years. Appropriate medical status for laparoscopic surgery (largest myoma ≤15 cm). No contra-indications to the use of glyopressin or carbitocin. Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility. Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks).

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: previous myomectomy; history of bleeding disorders; concurrent anticoagulation therapy.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

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

Nothing was hidden in this open-label Terlipressin study: the participants and staff both knew the treatment.

It started in 2022-02-27 with completion listed for 2024-12-30.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is prevention.

What Was Measured

It also tracked 2 secondary outcomes, for example effect of intramyometrial terlipressin vs carbitocin vs saline on operative time.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Terlipressin in 99 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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