NCT05266534

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Wael Elbanna Clinic · Academic / Other
• Sex: Female
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• Myoma

Interventions

Type	Name	Description
DRUG	Terlipressin	the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
DRUG	Carbetocin	the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
DRUG	Saline	the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy

Timeline

• Start date: 2021-12-30
• Primary completion: 2024-06-30
• Completion: 2026-12-30
• First posted: 2022-03-04
• Last updated: 2022-03-04

Locations

1 site across 1 country: Egypt