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Our study aims to evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin injection on hemoglobin level in women undergoing abdominal laparoscopic 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.
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 |
|---|---|---|---|
| intracapsular myomectomy Terlipressin injection | Active Comparator | intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure |
|
| intracapsular myomectomy Carbetocin injection | Active Comparator | intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure |
|
| intramyometrial saline | Placebo Comparator | intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terlipressin | Drug | intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy | measure the amount of blood loss in mm after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin | compare the hemoglobin level before and after operation after intracapsular injection of Terlipressin versus Carbetocin saline as aplacebo in women undergoing laparoscopic myomectomy | 24 hours |
| 2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time |
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Inclusion Criteria
Exclusion Criteria:
women have multiple myomectomy undergoing laparoscopic myomectomy
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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 |
|---|---|---|---|
| 23498888 | Background | Marsh EE, Ekpo GE, Cardozo ER, Brocks M, Dune T, Cohen LS. Racial differences in fibroid prevalence and ultrasound findings in asymptomatic young women (18-30 years old): a pilot study. Fertil Steril. 2013 Jun;99(7):1951-7. doi: 10.1016/j.fertnstert.2013.02.017. Epub 2013 Mar 15. | |
| 30056355 | Background | Srivastava S, Mahey R, Kachhawa G, Bhatla N, Upadhyay AD, Kriplani A. Comparison of intramyometrial vasopressin plus rectal misoprostol with intramyometrial vasopressin alone to decrease blood loss during laparoscopic myomectomy: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:279-283. doi: 10.1016/j.ejogrb.2018.07.006. Epub 2018 Jul 5. |
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| 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 |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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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 materials that will be used will include blood tests and ultrasound. The study will involve three study arms:
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|
2. To measure the operative time in minutes after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy |
| 12 hours |
| 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 |