Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery

Sponsor
Sevil Cankaya
Study ID
NCT07746349
Status
Not Yet Recruiting

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Conditions

  • Leiomyoma
  • Uterine Fibroids (Leiomyoma)
  • Uterine Myoma

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 5, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Terlipressin Group
    Subcapsular injection of 1 mg terlipressin diluted in 40 mL normal saline, administered prior to fibroid enucleation during myomectomy
  • Placebo Comparator: Placebo Group
    Subcapsular injection of 40 mL normal saline (no active drug), administered prior to fibroid enucleation during myomectomy

Primary Outcome Measure

Intraoperative Blood Loss [ Time Frame: Intraoperative period (from skin incision to skin closure) ]

Central Contacts

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