Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorSevil Cankaya

About this trial

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

Qualifiers

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

Disqualifiers

History of bleeding disorders or coagulopathy

Current anticoagulant or antiplatelet therapy

Known hypersensitivity or contraindication to terlipressin

Uncontrolled hypertension

Trial design

Treatments tested in this trial

  • terlipressin (vasoconstrictor)
  • Placebo

Treatment groups

80 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Sevil Cankaya

Lead sponsor

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

Sponsor institution