- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362399
Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants were randomized in 1:1 ratio into one of the following drug regime:
Group (I): "sildenafil citrate group" This group consisted of 22 women who received single oral dose of 50 mg sildenafil citrate.
Group (II): "placebo group" This group consisted of 22 women who received single oral dose of placebo. All participants were evaluated by ultrasound once they admitted and again after 2-hours following administration of either of the treatment tablets. One sonographer was allocated to evaluate all mothers included in the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Shebin Elkom, Egypt
- Menoufia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients were admitted to the study based on the following inclusion criteria:
- Any age and any party.
- Body mass index between 25 and 35.
- Singleton pregnancy.
- 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.
- Idiopathic intrauterine growth restriction.
- Intrauterine growth restriction due to maternal malnutrition, maternal medical disorder as anemia, pregnancy induced hypertension, or chronic renal disease.
- Intrauterine growth restriction due to substance abuse (including smoking).
- With or without past history of intrauterine growth restriction .
Exclusion Criteria:
- Intrauterine growth restriction due to fetal causes as congenital abnormalities, fetal infection, or multiple gestation.
- Any drug therapy that can affect fetal growth or fetal blood supply.
- Maternal diseases that contraindicates the use of sildenafil citrate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: sildenafil citrate
50 mg single oral dose
|
single oral dose of 50 mg
|
Active Comparator: placebo
single tablet of placebo
|
single oral dose of placebo tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
improvement of the Doppler indices following treatment
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- menoufia ob/gyn 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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