The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations

Last updated: June 24, 2024
Sponsor: Wael Elbanna Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Uterine Fibroids

Treatment

Terlipressin

Clinical Study ID

NCT05170230
Elbanna_006
  • Ages 16-45
  • Female

Study Summary

Our study aims to evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin injection on hemoglobin level in women undergoing abdominal laparoscopic myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.

Eligibility Criteria

Inclusion

Inclusion Criteria

  1. Women aged 16-45 years

  2. Appropriate medical status for laparoscopic surgery (largest myoma ≤15 cm)

  3. Baseline hemoglobin ≥9 g/dl

  4. No contra-indications to the use of glyopressin or carbitocin

  5. Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility

  6. Not pregnant at the time of presentation (i.e., negative urine pregnancy test orlast menstrual period within the last 4 weeks)

Exclusion

Exclusion Criteria:

  1. Previous myomectomy

  2. History of bleeding disorders

  3. Concurrent anticoagulation therapy

  4. History of Uncontrolled ischaemic heart disease

  5. Any pelvic abnormalities requiring concomitant surgery

  6. Treatment with a GnRH agonist or ulipristal acetate within three months precedingsurgery

  7. Inability to understand and provide written informed consent

Study Design

Total Participants: 99
Treatment Group(s): 1
Primary Treatment: Terlipressin
Phase:
Study Start date:
February 27, 2022
Estimated Completion Date:
June 30, 2026

Study Description

This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. Data will be pooled and presented in aggregate, without the identification of individual subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:

  • Arm 1: intramyometrial injection of Terlipressin in women undergoing laparoscopic myomectomy procedure

  • Arm 2: intramyometrial injection of Carbetocin in women undergoing laparoscopic myomectomy procedure

  • Arm 3: intramyometrial injection of saline in women undergoing laparoscopic myomectomy procedure Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computer-generated randomization table with a 1:1:1 group allocation.

Connect with a study center

  • Wael El Banna Clinic

    Maadi,
    Egypt

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.