Actively Recruiting
Comparing Intramyometrial Terlipressin and Carbetocin Injections to Reduce Blood Loss and Improve Hemoglobin in Women Undergoing Open Myomectomy Without Tourniquets
Led by Wael Elbanna Clinic · Updated on 2022-03-04
162
Participants Needed
1
Research Sites
130 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of intramyometrial injections of Terlipressin versus Carbetocin on hemoglobin levels and blood loss in women undergoing open myomectomy without the use of haemostatic tourniquets. This prospective, comparative, double-blinded randomized placebo-controlled trial aims to provide clinical evidence to guide best practices and improve outcomes for women with myoma undergoing this surgery. The study is conducted at multiple centers and includes women with relevant myoma-related symptoms. Participants are randomly assigned to one of three groups receiving intramyometrial Terlipressin, Carbetocin, or a saline injection during their open myomectomy procedure. The study excludes the use of mechanical tourniquets in all groups. The treatments are administered during surgery, and the groups are balanced with a 111 allocation ratio using computer-generated randomization. During the study, women will have their blood loss measured during surgery and hemoglobin levels monitored before and after the operation. Additional assessments include operative time and pain severity using a visual analog scale within 24 hours post-surgery. Blood tests and ultrasound are used for evaluations, and all data are collected confidentially. Safety and outcomes are monitored closely, with participation lasting through the immediate perioperative period up to 24 hours after surgery.
CONDITIONS
Brief Title
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets
Research Team
W
Wael El Banna
E
Esraa mohammad
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