About this trial
A myomectomy is a surgery to remove noncancerous growths (fibroids) from the uterus while keeping the uterus in place. This surgery can cause significant blood loss. Terlipressin is a medicine that narrows blood vessels and may help reduce bleeding.
This study will test whether injecting a diluted terlipressin solution under the outer covering of the fibroid, before it is removed, reduces the amount of blood lost during surgery, compared to an inactive solution (placebo). Women scheduled for myomectomy will be randomly assigned to receive either terlipressin or placebo. Neither the patients nor the surgical team will know which one was given until the study is finished. The main question this study will answer is how much blood is lost during surgery in each group.
Eligibility criteria
Qualifiers
Symptomatic uterine fibroid(s) with an indication for myomectomy, including menorrhagia, pelvic pain/pressure, or infertility
Largest myoma diameter between 4 and 10 cm
Baseline hemoglobin ≥ 9 g/dL
Not pregnant at the time of enrollment
Disqualifiers
History of bleeding disorders or coagulopathy
Current anticoagulant or antiplatelet therapy
Known hypersensitivity or contraindication to terlipressin
Uncontrolled hypertension
Trial design
Treatments tested in this trial
- terlipressin (vasoconstrictor)
- Placebo
Treatment groups
Locations
Sponsors and collaborators
Sevil Cankaya
Lead sponsor
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor institution