Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07746349

Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery

Conditions: Uterine Fibroids (Leiomyoma), Uterine Myoma, Leiomyoma

Sex: Female
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Sevil Cankaya

Summary

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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07746349). StuddyBuddy aggregates publicly available trial information.