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

Not Applicable

Recruiting

• Conditions: Myoma
• Interventions: Drug: Carbetocin; Drug: Saline; Drug: Terlipressin

• Registration Number: NCT05266534
• Lead Sponsor: Wael Elbanna Clinic

Brief 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

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-21
• Study Start: 2021-12-30
• Study First Submitted QC: 2022-02-23
• Last Update Submitted: 2022-02-23
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04
• Primary Completion: 2024-06-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intramyometrial Carbetocin injection in women undergoing open myomectomy	Carbetocin	intramyometrial Carbetocin injection
intramyometrial saline injection in women undergoing open myomectomy procedure	Saline	intramyometrial saline injection in women
intramyometrial Terlipressin injection in women undergoing open myomectomy	Terlipressin	intramyometrial Terlipressin injection

Primary Outcome Measures

Name	Time	Method
To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets	12 hours	the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wael El Banna Clinic; 🇪🇬 Maadi, Egypt