RecruitingNot ApplicableNCT05266534

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

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


Sponsor

Wael Elbanna Clinic

Enrollment

162 participants

Start Date

Dec 30, 2021

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 16 YearsMax Age: 40 Years

Inclusion Criteria6

  • 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 Criteria8

  • 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

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Interventions

DRUGTerlipressin

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

DRUGCarbetocin

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

DRUGSaline

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


Locations(1)

Wael El Banna Clinic

Maadi, Egypt

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NCT05266534


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