The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:

What Was Tested

This registered not phased trial tested Terlipressin.

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

Intramyometrial Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets. (After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural Terlipressin will be injected, and then the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated).

Intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets. (After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural carbitocin will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated).

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.

Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study.

Who Took Part

Enrollment: 99 actual participants took part.

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 open surgery (Largest Myoma size from 4 cm up to 20 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.

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.

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2022-02-01 with completion listed for 2024-03-29.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What This Means in Plain Language

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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