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Comparison of efficacy of rectal misoprostol for reduction amount of blood loss in women undergoing myomectomy, both open and laparoscopic approach
According to development of reproductive technology to assist infertile women, rate of myomectomy increases. During this operation, surgeons would deal with hypervascular masses with raw surfaces that tend to bleeding. Interventions to diminish bleeding were studied such as using misoprostol, vasopressin, transamenic acid along with mechanical intervention such as tourniquet and uterine artery ligation. But in Rajavithi hospital, such procedures aren't generally used because of fewer cases and also lacks of supporting data. Misoprostol, used in gynecologic patients for a long time with a wide safety margin acts at prostaglandin receptors of myometrium to stimulate contraction that constricts uterine vessels that lead to decreasing amount of bleeding during the operation. This led to the experimental study of rectal misoprostol administered at 15 - 30 minutes prior the operation to decrease blood loss and also blood transfusion rates. Our study also gather data about adverse effect that subject experienced after drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation |
|
| B | Placebo Comparator | Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal Misoprostol | Drug | Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean intraoperative blood loss in both groups | Within 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference of hemoglobin | within 24 hours | |
| Incidence of blood transfusion | within 72 hours | |
| Incidence of unplanned operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi hospital | Bangkok | 10400 | Thailand |
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| Placebo | Drug | Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation |
|
|
| within 72 hours |
| Incidence of adverse events | within 72 hours |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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