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
118 participants
INTERVENTIONAL
2019-09-25
2020-06-30
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
60 minutes before the surgery 3 mg of dinoprostone inserted vaginally
Dinoprostone 3 mg
1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery
placebo
60 minutes before the surgery 1 tablet of placebo inserted vaginally
placebo
1 vaginal tablet of placebo 60 minutes before surgery
Interventions
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Dinoprostone 3 mg
1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery
placebo
1 vaginal tablet of placebo 60 minutes before surgery
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Pre-operative hemoglobin \>8 g/dl
* Willing to have dinoprostone or a placebo prior to hysterectomy
* Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
* Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.
* Patients currently undergoing treatment for any type of cancer.
* Patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism)
* History of allergic reactions to dinoprostone.
18 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: STUDY_DIRECTOR
Cairo University
ayman taher, MD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
ahmed S Ali
Role: PRINCIPAL_INVESTIGATOR
faculty of medicine al-azhar university
Locations
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Ahmed Samy
Giza, , Egypt
Countries
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Other Identifiers
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dinoprostone hysterectomy
Identifier Type: -
Identifier Source: org_study_id
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