Status:
RECRUITING
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets
Lead Sponsor:
Wael Elbanna Clinic
Conditions:
Myoma
Eligibility:
FEMALE
16-40 years
Phase:
NA
Brief 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...
Detailed Description
This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT05266534
Start Date
December 30 2021
End Date
December 30 2026
Last Update
March 4 2022
Active Locations (1)
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1
Wael El Banna Clinic
Maadi, Egypt