Status:
COMPLETED
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:
Lead Sponsor:
Wael Elbanna Clinic
Conditions:
Myoma
Eligibility:
FEMALE
16-45 years
Phase:
NA
Brief Summary
the study aims to evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing abdominal myomectomy. Moreover, to...
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
- Women aged 16-45 years
- Appropriate 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2024
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT05242783
Start Date
February 1 2022
End Date
June 20 2024
Last Update
June 25 2024
Active Locations (1)
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1
Wael El-Banna Clinic
Maadi, Cairo Governorate, Egypt