The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets (myomectomy)

The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets.

For gynecologists, reaching a conclusion about the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. Besides enriching the clinical evidence in open myomectomy without using haemostatic tourniquets. For society, our conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for women undergoing open myomectomy without using haemostatic tourniquets.

Study Overview

• Status: Recruiting
• Conditions: Myoma
• Intervention / Treatment: Drug: Terlipressin; Drug: Carbetocin; Drug: Saline

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 without using haemostatic tourniquets
• Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
• Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure without using haemostatic tourniquets 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 computergenerated randomization table with a 1:1:1 group allocation

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

Contacts and Locations

Study Locations

• Egypt
  • Maadi, Egypt
    • Recruiting
    • Wael El Banna Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteri

• Women aged 16-45 yearsAppropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm)
• Baseline hemoglobin ≥9 g/dl
• No contra-indications to the use of glyopressin or carbitocin
• Myoma-related symptoms, such as pelvic pressure or pain,menorrhagia, or infertility
• Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks)

Exclusion Criteria

• Open myomectomy using mechanical tourniquet
• Previous myomectomy
• History of bleeding disorders
• Concurrent anticoagulation therapy
• History of Uncontrolled ischaemic heart disease
• Any pelvic abnormalities requiring concomitant surgery
• Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
• 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
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: intramyometrial Terlipressin injection in women undergoing open myomectomy; intramyometrial Terlipressin injection	Drug: Terlipressin; the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy; Other Names: glypressin
ACTIVE_COMPARATOR: intramyometrial Carbetocin injection in women undergoing open myomectomy; intramyometrial Carbetocin injection	Drug: Carbetocin; the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy; Other Names: pabal
PLACEBO_COMPARATOR: intramyometrial saline injection in women undergoing open myomectomy procedure; intramyometrial saline injection in women	Drug: Saline; the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy; Other Names: NaCl 0.9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets	the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets	To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets	24 hours
To measure the operative time in each group without using haemostatic tourniquets	To measure the operative time in each group without using haemostatic tourniquets	24 hours
to assess the measure the severity of pain using VAS score	post operative pain VAS score	24 hours

Collaborators and Investigators

• Sponsor: Wael Elbanna Clinic

Publications and helpful links

General Publications

• 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 Jan;25(1):187-188. doi: 10.1016/j.jmig.2017.07.027. Epub 2017 Aug 18. No abstract available.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2021
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): December 30, 2026

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (ACTUAL): March 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Antihypertensive Agents; Reproductive Control Agents; Oxytocics; Vasoconstrictor Agents; Terlipressin; Carbetocin
• Other Study ID Numbers: Elbanna_008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No