The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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:
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Arm 1: intramyometrial Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
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Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: intramyometrial Terlipressin injection intramyometrial Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets. (After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural Terlipressin will be injected, and then the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated) |
Drug: Terlipressin
intramyometrial Terlipressin versus carbitocin versus saline(placebo) injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
Other Names:
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| Active Comparator: intramyometrial Carbetocin injection intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets. (After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural carbitocin will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated) |
Drug: Terlipressin
intramyometrial Terlipressin versus carbitocin versus saline(placebo) injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
Other Names:
|
| Placebo Comparator: intramyometrial saline injection intramyometrial saline injection in women undergoing open myomectomy procedure using haemostatic tourniquets. After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural saline as a aplacebo will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated) and amount of blood loss and operative time is compared between all arms |
Drug: Terlipressin
intramyometrial Terlipressin versus carbitocin versus saline(placebo) injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets. [12 hours]
To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets( measuring the amount of blood loss in mm )
Secondary Outcome Measures
- 1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets. [24 hours]
1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets. ( to evaluate the change in hemoglobin level between before and after the operation )
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women aged 16-45 years
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Appropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm)
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Baseline hemoglobin ≥9 g/dl
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No contra-indications to the use of glyopressin or carbitocin
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Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility
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Not pregnant at the time of presentation
Exclusion Criteria:
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Previous myomectomy
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History of bleeding disorders
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Concurrent anticoagulation therapy
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History of Uncontrolled ischaemic heart disease
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Any pelvic abnormalities requiring concomitant surgery
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Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
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Inability to understand and provide written informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wael El-Banna Clinic | Maadi | Cairo | Egypt |
Sponsors and Collaborators
- Wael Elbanna Clinic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Elbanna_007