Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy

What Was Tested

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

It had two arms (groups): Intramyometrial Ergometrine Injection (active comparator) and Intramyometrial Carbetocin Injection (experimental).

Participants receive intramyometrial injection of methylergometrine maleate diluted in saline and administered circumferentially around the myoma before uterine incision during abdominal myomectomy.

Participants receive intramyometrial injection of carbetocin diluted in saline and administered circumferentially around the myoma before uterine incision during abdominal myomectomy.

The registry classes the interventions as drug.

More on the Plan

Uterine leiomyomas are the most common benign tumors of the female reproductive tract and frequently require surgical management when symptomatic.

Abdominal myomectomy remains the standard fertility-preserving surgical option for women with large or multiple intramyometrial fibroids.

Despite their individual use, comparative data on their intramyometrial administration during abdominal myomectomy remain limited.

To minimize bias, all procedures will be performed by the same surgical team following a standardized operative technique.

Who Took Part

40 planned participants were the target.

It was open to women only aged from 25 years up to 48 years.

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

Examples of who could join: Female participants aged 25 to 48 years. Body mass index (BMI) \< 35 kg/m². Symptomatic uterine fibroids requiring surgical management (e.g., abnormal uterine bleeding, pelvic pain, or pressure symptoms). Intramyometrial uterine myomas classified as FIGO types 3 to 6, diagnosed by transvaginal ultrasonography or magnetic resonance imaging. Maximum diameter of the largest myoma ≤ 20 cm.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: FIGO type 0, 1, 2, 7, or 8 myomas (intracavitary, submucosal, pedunculated subserosal, cervical, or adnexal); history of prior uterine surgery; use of hormonal treatment within 3 months prior to enrollment.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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

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

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2026-01-18 with completion listed for 2026-07-30.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Estimated Intraoperative and Postoperative Blood Loss (time frame: From the start of surgery until removal of the intraperitoneal drain (up to 48 hours postoperatively)).

It also tracked 6 secondary outcomes, for example Need for Blood Transfusion, Change in Postoperative Hemoglobin and Hematocrit Levels, Incidence of Drug-Related Side Effects, Duration of Surgery, Postoperative Febrile Morbidity and Length of Postoperative Hospital Stay.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carbetocin in 40 people.

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

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