Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy
NCT ID: NCT02709564
Last Updated: 2020-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2016-12-31
2020-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group A
400 mg placebo
placebo 400 sublingual
patients will take 2 tablets of sublingual placebo 400 microgram 1 hour before the surgery
Group B
400 microgram misoprostol
Misoprostol 400 sublingual
patients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery
Interventions
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Misoprostol 400 sublingual
patients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery
placebo 400 sublingual
patients will take 2 tablets of sublingual placebo 400 microgram 1 hour before the surgery
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years and ≤ 50 years
* Pre-operative hemoglobin \>8 g/dl
* Ability to understand and the willingness to sign a written informed consent.
* Admissible medical/surgical history
* Five or less symptomatic uterine myomas
* All myomas are subserous or intramural.
* Uterine size less than 24 weeks pregnancy
Exclusion Criteria
* Post-menopausal women
* Patients with known bleeding/clotting disorders
* Patients with a history of gynecologic malignancy
* Hypertension.
* Cardiac and Pulmonary diseases.
* Obesity (body mass index \> 30 kg/m2).
* History of allergic reactions attributed to misoprostol
* Cases that will require intraoperative conversion of myomectomy to hysterectomy.
18 Years
50 Years
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Mohamed Abbas
Dr
Locations
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Ahmed Abbas
Assiut, Cairo Governorate, Egypt
Countries
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Other Identifiers
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misop 2
Identifier Type: -
Identifier Source: org_study_id
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