Clinical trial · Interventional
Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery
Efficacy of Subcapsular Diluted Terlipressin Versus Placebo in Reducing Intraoperative Blood Loss During Myomectomy: A Randomized, Double-Blind, Placebo-Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Uterine Fibroids (Leiomyoma) | Uterine Corpus Leiomyoma | ALIAS | 0.85 |
| Uterine Myoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| terlipressin (vasoconstrictor) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Terlipressin Group
- description
- Subcapsular injection of 1 mg terlipressin diluted in 40 mL normal saline, administered prior to fibroid enucleation during myomectomy
- interventionNames
- Drug: terlipressin (vasoconstrictor)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Subcapsular injection of 40 mL normal saline (no active drug), administered prior to fibroid enucleation during myomectomy
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Intraoperative Blood Loss
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (3)
- RESULTTaher 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 Steril. 2021 Mar;115(3):793-801. doi: 10.1016/j.fertnstert.2020.09.132. Epub 2021 Jan 16. PMID 33461754
- RESULTElbanna 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
- RESULTMatasariu 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