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
PHASE4
410 participants
INTERVENTIONAL
2020-09-01
2022-07-31
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
DOUBLE
Study Groups
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study group
50 mg oral sildenafil citrate tablet
Sildenafil 50 mg
50 mg oral Sildenafil tablet
placebo group
placebo tablets of the same shape, color and size of sildenafil citrate tablets
Placebo oral tablet
placebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy
Interventions
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Sildenafil 50 mg
50 mg oral Sildenafil tablet
Placebo oral tablet
placebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy
Eligibility Criteria
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Inclusion Criteria
2. Pregnant ≥ 37 weeks gestation.
3. Fetus with longitudinal lie and vertex presentation.
4. Healthy fetus with EFW\>2500 gm
Exclusion Criteria
2. Antepartum hemorrhage.
3. Cephalopelvic disproportion.
4. Category II or III non-stress test.
5. Medical disease as hypertension, cardiac, renal and hepatic disorders
6. Intrauterine fetal death.
7. Fetal growth restriction.
8. Fetuses with major congenital malformations.
9. Women taking any anti-hypertensive medication, alpha-adrenergic blocking agents, calcium channel blockers (verapamil), nitrates, medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors.
10. Women with a contra-indication to sildenafil treatment such as hypersensitivity to sildenafil.
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Mohamed Abbas
Principal investigator
Locations
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Ahmed Abbas
Assiut, Cairo Governorate, Egypt
Countries
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Other Identifiers
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SC-IPFD
Identifier Type: -
Identifier Source: org_study_id
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