The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:

The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets: Double Blinded Randomized Placebo-Controlled Trial

the study aims to evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing abdominal 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.

Study Overview

• Status: Recruiting
• Conditions: Myoma
• Intervention / Treatment: Drug: Terlipressin

Detailed 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 Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
• Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
• Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure using haemostatic tourniquets(placebo).

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

• Study Type: Interventional
• Enrollment (Anticipated): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Maadi, Cairo, Egypt
      • Recruiting
      • Wael El-Banna Clinic
      • Contact: Wael SS El-Banna, consultant; Phone Number: 01227760402; Email: dr.wael.ss.elbanna@gmail.com,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women aged 16-45 years
2. Appropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 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

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 preceding surgery
7. Inability to understand and provide written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intramyometrial Terlipressin injection; intramyometrial Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets. (After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural Terlipressin will be injected, and then the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated)	Drug: Terlipressin; intramyometrial Terlipressin versus carbitocin versus saline(placebo) injection in women undergoing open myomectomy procedure using haemostatic tourniquets.; Other Names: carbitocin; saline (placebo)
Active Comparator: intramyometrial Carbetocin injection; intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets. (After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural carbitocin will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated)	Drug: Terlipressin; intramyometrial Terlipressin versus carbitocin versus saline(placebo) injection in women undergoing open myomectomy procedure using haemostatic tourniquets.; Other Names: carbitocin; saline (placebo)
Placebo Comparator: intramyometrial saline injection; intramyometrial saline injection in women undergoing open myomectomy procedure using haemostatic tourniquets. After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural saline as a aplacebo will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated) and amount of blood loss and operative time is compared between all arms	Drug: Terlipressin; intramyometrial Terlipressin versus carbitocin versus saline(placebo) injection in women undergoing open myomectomy procedure using haemostatic tourniquets.; Other Names: carbitocin; saline (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets.	To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets( measuring the amount of blood loss in mm )	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets.	1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets. ( to evaluate the change in hemoglobin level between before and after the operation )	24 hours

Collaborators and Investigators

• Sponsor: Wael Elbanna Clinic

Publications and helpful links

General Publications

• Song T, Kim MK, Kim ML, Jung YW, Yun BS, Seong SJ. Use of vasopressin vs epinephrine to reduce haemorrhage during myomectomy: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:177-181. doi: 10.1016/j.ejogrb.2015.10.003. Epub 2015 Oct 24.
• Parker WH, Berek JS, Pritts EA, Olive D, Chalas E, Clarke-Pearson D. Regarding "Incidence of Occult Uterine Malignancy Following Vaginal Hysterectomy with Morcellation". J Minim Invasive Gynecol. 2018 Sep-Oct;25(6):1113. doi: 10.1016/j.jmig.2018.04.008. Epub 2018 Apr 18. No abstract available.

Helpful Links

• Related Info
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Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): August 30, 2024
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Antihypertensive Agents; Vasoconstrictor Agents; Terlipressin
• Other Study ID Numbers: Elbanna_007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No