Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery

Myomectomy is frequently complicated by significant intraoperative bleeding. While vasoconstrictive and uterotonic agents such as vasopressin, carbetocin, and undiluted terlipressin have been studied for hemostasis, no prior trial has evaluated a diluted terlipressin solution administered via the subcapsular route. This study aims to address this gap by comparing 1 mg terlipressin diluted in 40 mL normal saline, injected subcapsularly, versus placebo, with intraoperative blood loss as the primary outcome

Inclusion criteria

• 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
• Negative urine pregnancy test or last menstrual period within 4 weeks
• Willing and able to provide written informed consent

Exclusion criteria

• History of bleeding disorders or coagulopathy
• Current anticoagulant or antiplatelet therapy
• Known hypersensitivity or contraindication to terlipressin
• Uncontrolled hypertension
• Severe cardiac arrhythmia
• Uncontrolled ischemic heart disease
• Peripheral vascular disease
• Pregnancy or suspected pregnancy
• Previous myomectomy
• Concurrent pelvic pathology requiring additional surgical intervention
• Treatment with a GnRH agonist or ulipristal acetate within the 3 months preceding surgery
• Suspected uterine malignancy, such as leiomyosarcoma
• Inability to understand or provide informed consent