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Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery

ConditionsUterine Fibroids (Leiomyoma)Uterine MyomaLeiomyoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Terlipressin GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

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).

Time frame
Intraoperative period (from skin incision to skin closure)

Secondary outcomes

1

Change in Hemoglobin and Hematocrit Levels

Difference between preoperative and 24-hour postoperative hemoglobin (g/dL) and hematocrit (%) levels

Time frame
Baseline (preoperative) to 24 hours postoperative
2

Rate of Blood Transfusion

Proportion of participants requiring intraoperative or postoperative blood transfusion

Time frame
From surgery through hospital discharge
3

Duration of Surgery

Time from skin incision to skin closure, recorded in minutes

Time frame
Intraoperative period
4

Requirement for Supplementary Hemostatic Intervention

Proportion of participants requiring additional hemostatic measures (e.g., additional sutures, electrocautery) beyond the study intervention

Time frame
Intraoperative period

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sevil Cankaya

Lead sponsor

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

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: