Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery

Официальное название

Efficacy of Subcapsular Diluted Terlipressin Versus Placebo in Reducing Intraoperative Blood Loss During Myomectomy: A Randomized, Double-Blind, Placebo-Controlled Trial

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат terlipressin (vasoconstrictor)
  Terlipressin 1 mg diluted in 40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation
• Препарат Placebo
  40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation

Первичные конечные точки

• Intraoperative Blood Loss [Срок оценки: Intraoperative period (from skin incision to skin closure)]

Вторичные конечные точки (8)

• Change in Hemoglobin and Hematocrit Levels [Срок оценки: Baseline (preoperative) to 24 hours postoperative]
• Rate of Blood Transfusion [Срок оценки: From surgery through hospital discharge]
• Duration of Surgery [Срок оценки: Intraoperative period]
• Requirement for Supplementary Hemostatic Intervention [Срок оценки: Intraoperative period]
• Change in Blood Pressure [Срок оценки: Pre-injection through 30 minutes post-injection]
• Rate of Postoperative Complications [Срок оценки: Through hospital discharge (and 30-day follow-up, if planned)]
• Duration of Hospitalization [Срок оценки: From the day of surgery until hospital discharge]
• Change in Heart Rate [Срок оценки: Pre-injection through 30 minutes post-injection]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Taher A, Farouk D, Mohamed Kotb MM, Ghamry NK, Kholaif K, A Mageed A Allah A, Ali AS, Osman OM, Nabil H, Islam Y, Bakry MS, Islam BA, Alalfy M, Nassar SA, Bosilah AH, Ghanem AA, Ali Rund NM, Refaat R, Abdel Wahed Ali HA, Bakry A, Ashour ASA, Nabil M, Zaki SS. Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial. Fertil Ster PMID 33461754
• Elbanna W, Al Sheikh MM, Azmy OM. The effect of intramyometrial injection of terlipressin versus carbetocin on hemoglobin and blood loss during open myomectomy operations without using haemostatic tourniquets: Double blinded randomized placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2025 May;309:186-191. doi: 10.1016/j.ejogrb.2025.03.041. Epub 2025 Mar 22. PMID 40164039
• Matasariu DR, Ursache A, Himiniuc L, Toma B, Boiculese VL, Rudisteanu D, Dumitrascu I. A Romanian study on the impact of glypressin in laparoscopic myomectomy. Exp Ther Med. 2021 Sep;22(3):955. doi: 10.3892/etm.2021.10387. Epub 2021 Jul 6. PMID 34335897

Идентификаторы

NCT: NCT07746349 · 2025/490

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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