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In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy
Uterine fibroids are the most common female pelvic tumors occurring in about 15% to 30% of women in the reproductive age group. The major problem with myomectomy is excessive bleeding from the increased uterine blood supply. This can be life-threatening, resulting in blood transfusions, febrile morbidity, and potentially in loss of reproductive potential from a hysterectomy. Knowledge of the effectiveness of the interventions used to reduce blood loss during myomectomy is essential to enable evidence-based clinical decisions. Topical application of tranexamic acid(TA) provides a high drug concentration at the site of the wound and a low systemic concentration. Studies from cardiac and orthopedic surgery have shown an equal or superior effect of topical compared with intravenous TA on both bleeding and transfusion requirement. Topical treatment is cost-effective, and adverse effects or drug interactions have not been reported
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical TA plus vasopressin | Active Comparator | Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9% |
|
| placebo to TA plus vasopressin | Active Comparator | Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus placebo to tranexamic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical TA | Drug | A gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9% |
|
| Measure | Description | Time Frame |
|---|---|---|
| measure will be Mean amount of blood loss | measure will be Mean amount of blood loss by gravimetric methods | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| the number of the patients need of blood transfusion | calculate the number of the patients need of blood transfusion | 24 hours post delivery |
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Inclusion Criteria:
Exclusion Criteria:
All women who prepared for abdominal myomectomies will be invited to participate in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f allam, md | Contact | 0102236052 | 002 | hany.farouk@aswu.edu.eg |
| nahla w shady, md | Contact | 01092440504 | 002 | nahla.elsayed@aswu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| hany f allam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University Hospital | Recruiting | Aswān | 81528 | Egypt |
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| ID | Term |
|---|---|
| D009214 | Myoma |
| D003919 | Diabetes Insipidus |
| 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 |
|---|---|
| D014667 | Vasopressins |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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A double-blinded randomized controlled stud
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A double-blinded randomized controlled stud
| vasopressin | Drug | intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy |
|
|
| placebo to TA | Other | (120 ml of sodium chloride 0.9%) used to compress the myoma bed for 5 min. |
|
|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| 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 |