NCT05242783

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Wael Elbanna Clinic · Academic / Other
• Sex: Female
• Age: 16 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Myoma

Interventions

Type	Name	Description
DRUG	Terlipressin	intramyometrial Terlipressin versus carbitocin versus saline(placebo) injection in women undergoing open myomectomy procedure using haemostatic tourniquets.

Timeline

• Start date: 2022-02-01
• Primary completion: 2024-03-29
• Completion: 2024-06-20
• First posted: 2022-02-16
• Last updated: 2024-06-25

Locations

1 site across 1 country: Egypt