The Effect of Intracapsular Injection of Terlipressin Versus 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): intracapsular myomectomy Terlipressin injection (active comparator), intracapsular myomectomy Carbetocin injection (active comparator) and intramyometrial saline (placebo comparator).

Intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure.

Intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure.

Intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure.

The registry classes the interventions as drug.

More on the Plan

The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants.

Data will be pooled and presented in aggregate, without the identification of individual subjects.

The study materials that will be used will include blood tests and ultrasound.

Women will be randomized to one of the three arms using a computer-generated randomization table with a 1:1:1 group allocation.

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 randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Terlipressin and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Terlipressin.

Those kept unaware of assignments: participant, care provider and investigator.

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

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy (time frame: 12 hours).

What This Means in Plain Language

Put simply, this is a not phased, 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.