Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery

NCT07746349 | Not Yet Recruiting

• 1 other identifier: 2025/490
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Uterine Fibroids (Leiomyoma); Uterine Myoma; Leiomyoma

Keywords

Terlipressin; Myomectomy; Uterine Fibroids; Subcapsular Injection; Intraoperative Blood Loss; Vasopressin Analog; Placebo-Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Intraoperative Blood Loss

  Blood loss will be measured gravimetrically as the difference in weight of surgical sponges and drapes before and after use, plus the volume collected in the suction canister, minus the volume of irrigation fluid used. The result will be expressed in milliliters (mL).

  Intraoperative period (from skin incision to skin closure)

Secondary Outcomes (8)

• Change in Hemoglobin and Hematocrit Levels

  Baseline (preoperative) to 24 hours postoperative

• Rate of Blood Transfusion

  From surgery through hospital discharge

• Duration of Surgery

  Intraoperative period

• Requirement for Supplementary Hemostatic Intervention

  Intraoperative period

• Change in Blood Pressure

  Pre-injection through 30 minutes post-injection

Study Arms (2)

Terlipressin Group

EXPERIMENTAL

Subcapsular injection of 1 mg terlipressin diluted in 40 mL normal saline, administered prior to fibroid enucleation during myomectomy

Drug: terlipressin (vasoconstrictor)

Placebo Group

PLACEBO COMPARATOR

Subcapsular injection of 40 mL normal saline (no active drug), administered prior to fibroid enucleation during myomectomy

Drug: Placebo

Interventions

terlipressin (vasoconstrictor) DRUG

Terlipressin 1 mg diluted in 40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation

Terlipressin Group

Placebo DRUG

40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation

Placebo Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sevil Cankaya: lead

Related Publications (3)

• 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 Steril. 2021 Mar;115(3):793-801. doi: 10.1016/j.fertnstert.2020.09.132. Epub 2021 Jan 16.

  PMID: 33461754 RESULT

• 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 RESULT

• 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 RESULT

Related Links

• A Romanian study on the impact of glypressin in laparoscopic myomectomy
• 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
• Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial

MeSH Terms

Conditions

Leiomyoma; Myofibroma

Interventions

Terlipressin; Vasoconstrictor Agents

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Sevil Çankaya, MD

  Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sevil Çankaya, MD

CONTACT

+90 505 866 34 09; sevilsaltek82@gmail.com

Ahmet Kale, MD

CONTACT

ahmetkale5@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Obstetrics and Gynecology Specialist

Model Details: Participants will be randomly allocated in a 1:1 ratio to receive either subcapsular diluted terlipressin or placebo (saline) injection prior to fibroid enucleation during myomectomy. Both groups will be followed using identical perioperative and postoperative assessment protocols.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 5, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share