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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Myoma

Intervention / Treatment
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* Drug: Terlipressin
* Drug: Carbetocin
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteri Women aged 16-45 yearsAppropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm) Baseline hemoglobin ≥9 g/dl No contra-indications to the use of glyopressin or carbitocin Myoma-related symptoms, such as pelvic pressure or pain,menorrhagia, or infertility Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks) Exclusion Criteria Open myomectomy using mechanical tourniquet Previous myomectomy History of bleeding disorders Concurrent anticoagulation therapy History of Uncontrolled ischaemic heart disease Any pelvic abnormalities requiring concomitant surgery Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery Inability to understand and provide written informed consent

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Blinded Randomized Placebo-Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intramyometrial Terlipressin injection in women undergoing open myomectomy<br>intramyometrial Terlipressin injection | Drug: Terlipressin<br>* the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy<br>* Other names: glypressin;|
| Active Comparator: intramyometrial Carbetocin injection in women undergoing open myomectomy<br>intramyometrial Carbetocin injection | Drug: Carbetocin<br>* the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy<br>* Other names: pabal;|
| Placebo Comparator: intramyometrial saline injection in women undergoing open myomectomy procedure<br>intramyometrial saline injection in women | Drug: Saline<br>* the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy<br>* Other names: NaCl 0.9;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets | the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets | To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets | 24 hours | 
| To measure the operative time in each group without using haemostatic tourniquets | To measure the operative time in each group without using haemostatic tourniquets | 24 hours | 
| to assess the measure the severity of pain using VAS score | post operative pain VAS score | 24 hours |