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Clinical Trials in Egypt / NCT05266534
Recruiting Not applicable

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

NCT05266534 · tracked via the Priya Life Science Egypt tracker
Sponsor
Wael Elbanna Clinic
Phase
Not applicable
Started
2021-12-30
Last updated
2022-03-04

Condition(s) studied

Myoma

Investigational drug(s) / intervention(s)

Terlipressin →Carbetocin →Saline

Terlipressin: the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy

Carbetocin: the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy

Saline: the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy

Study summary

For gynecologists, reaching a conclusion about the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. Besides enriching the clinical evidence in open myomectomy without using haemostatic tourniquets. For society, our conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for women undergoing open myomectomy without using haemostatic tourniquets.

Eligibility

Sex
FEMALE
Min age
16 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteri * Women aged 16-45 yearsAppropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm) * Baseline hemoglobin ≥9 g/dl * 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) Exclusion Criteria * Open myomectomy using mechanical tourniquet * Previous myomectomy * History of bleeding disorders * Concurrent anticoagulation therapy * History of Uncontrolled ischaemic heart disease * Any pelvic abnormalities requiring concomitant surgery * Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery * Inability to understand and provide written informed consent

Primary outcome measure(s)

  • To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets — 12 hours
    the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets

Trial sites (1)

FacilityCityRegionStatus
Wael El Banna Clinic Maadi Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05266534 on ClinicalTrials.gov ↗ ← All trials in Egypt