Sildenafil Citrate for Treatment of Growth-restricted Fetuses
NCT ID: NCT03177824
Last Updated: 2017-06-09
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
60 participants
INTERVENTIONAL
2017-03-30
2017-10-01
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
TREATMENT
TRIPLE
Study Groups
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S
Sildenafil citrate (25mg)
Sildenafil Citrate 25Mg Tab
Group 1, consists of 30 patients who will receive Sildenafil citrate (25mg) tab (Silden, Epico, Egypt) 3times daily till the time of delivery, followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score.
P
placebo oral tablet
Placebo Oral Tablet
Group 2, consists of 30 patients receiving placebo Oral Tablet 3times daily , followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score
Interventions
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Sildenafil Citrate 25Mg Tab
Group 1, consists of 30 patients who will receive Sildenafil citrate (25mg) tab (Silden, Epico, Egypt) 3times daily till the time of delivery, followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score.
Placebo Oral Tablet
Group 2, consists of 30 patients receiving placebo Oral Tablet 3times daily , followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score
Eligibility Criteria
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Inclusion Criteria
* Gestational age 28-37 weeks.
Exclusion Criteria
* Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss.
* Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin.
* Fetal distress.
* Pregnancy of multiple fetuses.
* Congenital fetal malformation or chromosomal abnormalities.
* Diastolic blood pressure more than 110 mmHg.
* Hypersensitivity to the drug.
20 Years
40 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Shaimaa Mohamed Ezz el din
resident of obstetrics and gynecology
Locations
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Ain Shams matrnity hospital
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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123sc
Identifier Type: -
Identifier Source: org_study_id
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