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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02362399 |
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Date of registration:
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05/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses
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Scientific title:
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Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02362399 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Egypt
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients were admitted to the study based on the following inclusion criteria:
1. Any age and any party.
2. Body mass index between 25 and 35.
3. Singleton pregnancy.
4. Gestational age of 24 weeks or more. Gestational age was established on the basis of
menstrual dates and confirmed by first or second trimester ultrasound for booked
patients, however, if a difference of > 7 days or > 10 days during first or second
trimester respectively, then ultrasound value was used. For unbooked patients they
still have the chance to be included in our study if they can bring a scan that
showed gestational age during the same period mentioned before.
5. Idiopathic intrauterine growth restriction.
6. Intrauterine growth restriction due to maternal malnutrition, maternal medical
disorder as anemia, pregnancy induced hypertension, or chronic renal disease.
7. Intrauterine growth restriction due to substance abuse (including smoking).
8. With or without past history of intrauterine growth restriction .
Exclusion Criteria:
1. Intrauterine growth restriction due to fetal causes as congenital abnormalities,
fetal infection, or multiple gestation.
2. Any drug therapy that can affect fetal growth or fetal blood supply.
3. Maternal diseases that contraindicates the use of sildenafil citrate
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy Complication
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Intervention(s)
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Drug: sildenafil citrate
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Other: placebo
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Primary Outcome(s)
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improvement of the Doppler indices following treatment
[Time Frame: 9 months]
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Secondary ID(s)
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menoufia ob/gyn 1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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