Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy
NCT ID: NCT04080375
Last Updated: 2019-09-06
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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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2019-09-10
2019-12-10
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
QUADRUPLE
Study Groups
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dinoprostone 3 mg
patients will take 1 tablet of vaginal dinoprostone 1 hour before the surgery
Dinoprostone 3 mg
the patient will take one vaginal tablet of 3 mg dinoprostone 1 hour before surgery
placebo
patients will take 1 tablet of placebo 1 hour before the surgery
placebo
the patient will take one vaginal tablet of placebo 1 hour before surgery
Interventions
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Dinoprostone 3 mg
the patient will take one vaginal tablet of 3 mg dinoprostone 1 hour before surgery
placebo
the patient will take one vaginal tablet of placebo 1 hour before 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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Cairo University
OTHER
Responsible Party
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Ahmed Samy aly ashour
assistant professor
Principal Investigators
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AHMED SAMY
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Central Contacts
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Other Identifiers
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dinoprostone myomectomy
Identifier Type: -
Identifier Source: org_study_id
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