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

Myoma Clinical Trial

Official title:

The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations: Double Blinded Randomized Placebo-Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05170230
• Other study ID #: Elbanna_006
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: October 2023
• Source: Wael Elbanna Clinic
• Contact: Wael El Banna
• Phone: 01227760402
• Email: waelelbanna[@]drwaelelbanna.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 30, 2026
• Est. primary completion date: December 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 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 or last menstrual period within the last 4 weeks)

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
intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy

Locations

Country	Name	City	State
Egypt	Wael El Banna Clinic	Maadi

Sponsors (1)

Lead Sponsor	Collaborator
Wael Elbanna Clinic

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Marsh EE, Ekpo GE, Cardozo ER, Brocks M, Dune T, Cohen LS. Racial differences in fibroid prevalence and ultrasound findings in asymptomatic young women (18-30 years old): a pilot study. Fertil Steril. 2013 Jun;99(7):1951-7. doi: 10.1016/j.fertnstert.2013.02.017. Epub 2013 Mar 15. — View Citation

Srivastava S, Mahey R, Kachhawa G, Bhatla N, Upadhyay AD, Kriplani A. Comparison of intramyometrial vasopressin plus rectal misoprostol with intramyometrial vasopressin alone to decrease blood loss during laparoscopic myomectomy: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:279-283. doi: 10.1016/j.ejogrb.2018.07.006. Epub 2018 Jul 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy	measure the amount of blood loss in mm after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy	12 hours
Secondary	1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin	compare the hemoglobin level before and after operation after intracapsular injection of Terlipressin versus Carbetocin saline as aplacebo in women undergoing laparoscopic myomectomy	24 hours
Secondary	2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time	2. To measure the operative time in minutes after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy	12 hours

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