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The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications
This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital.
A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial.
The total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myomectomy, rectal Misoprostol | Experimental | 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation. |
|
| Myomectomy, Placebo | Active Comparator | Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative blood loss | time from peritoneum opening till its closure around (1 Hour) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abd El Mgeed I. Abd El Mgeed, Professor | Ain Shams University | Study Chair |
| Mohamed S. Ali, Professor | Ain Shams University | Study Director |
| Mohamed A. Abdel-Hafeez, Lecturer | Ain Shams University | Principal Investigator |
| Mina A. Yacoup, Fellow | Ain Shams University | Principal Investigator |
| Ahmed M. Elnaggar, Lecturer | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University, Maternity Hospital | Cairo | Cairo Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26174128 | Derived | Abdel-Hafeez M, Elnaggar A, Ali M, Ismail AM, Yacoub M. Rectal misoprostol for myomectomy: A randomised placebo-controlled study. Aust N Z J Obstet Gynaecol. 2015 Aug;55(4):363-8. doi: 10.1111/ajo.12359. Epub 2015 Jul 14. |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| 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 |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
| Placebo( for misoprostol) | Drug | Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation. |
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |