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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intramyometrial Terlipressin injection in women undergoing open myomectomy | Active Comparator | intramyometrial Terlipressin injection |
|
| intramyometrial Carbetocin injection in women undergoing open myomectomy | Active Comparator | intramyometrial Carbetocin injection |
|
| intramyometrial saline injection in women undergoing open myomectomy procedure | Placebo Comparator | intramyometrial saline injection in women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terlipressin | Drug | the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy |
|
| 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 |
| 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 |
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Inclusion Criteri
Exclusion Criteria
women with utrine fibroids
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wael El Banna | Contact | 01227760402 | waelelbanna@drwaelelbanna.com | |
| Esraa mohammad | Contact | 01212421260 | esraamoghawry@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wael El Banna Clinic | Recruiting | Maadi | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28826956 | Background | Parker WH, Berek JS, Pritts EA, Olive D, Chalas E, Clarke-Pearson D. Regarding "Incidence of Occult Uterine Malignancy Following Vaginal Hysterectomy with Morcellation". J Minim Invasive Gynecol. 2018 Jan;25(1):187-188. doi: 10.1016/j.jmig.2017.07.027. Epub 2017 Aug 18. No abstract available. |
| Label | URL |
|---|---|
| Related Info | View source |
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Double Blinded Randomized Placebo-Controlled Trial
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Double Blinded Randomized Placebo-Controlled Trial
|
| Carbetocin | Drug | the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy |
|
|
| Saline | Drug | the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy |
|
|
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 |
| ID | Term |
|---|---|
| D009214 | Myoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| C020731 | carbetocin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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