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

Myoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242783
• Other study ID #: Elbanna_007
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2022
• Source: Wael Elbanna Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: December 30, 2025
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Myoma

Intervention

Drug:
• Terlipressin
intramyometrial Terlipressin versus carbitocin versus saline(placebo) injection in women undergoing open myomectomy procedure using haemostatic tourniquets.

Locations

Country	Name	City	State
Egypt	Wael El-Banna Clinic	Maadi	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Wael Elbanna Clinic

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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;195:177-81. doi: 10.1016/j.ejogrb.2015.10.003. Epub 2015 Oct 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

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