The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets

What Was Tested

In this not phased trial, researchers set out to test Terlipressin and Carbetocin.

It had three arms (groups): intramyometrial Terlipressin injection in women undergoing open myomectomy (active comparator), intramyometrial Carbetocin injection in women undergoing open myomectomy (active comparator) and intramyometrial saline injection in women undergoing open myomectomy procedure (placebo comparator).

Intramyometrial Terlipressin injection.

Intramyometrial Carbetocin injection.

Intramyometrial saline injection in women.

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 computergenerated randomization table with a 1:1:1 group allocation.

Who Took Part

The registry lists 162 planned participants were the target.

It was open to women only aged from 16 years up to 40 years.

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

Examples of who could join: Women aged 16-45 yearsAppropriate 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 (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks).

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: open myomectomy using mechanical tourniquet; previous myomectomy; history of bleeding disorders.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Terlipressin group and the comparison group should start out alike.

The Terlipressin group and the comparison group ran side by side rather than switching.

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

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

It started in 2021-12-30 with completion listed for 2024-06-30.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets (time frame: 12 hours).

It also tracked 3 secondary outcomes, for example To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets, To measure the operative time in each group without using haemostatic tourniquets and to assess the measure the severity of pain using VAS score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin and Carbetocin in 162 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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