Back to resultsRole of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages
Primary Purpose
Recurrent Miscarriage
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Sildenafil citrate
matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Miscarriage focused on measuring sildenafil citrate, Doppler Ultrasonography, nitric oxide, total antioxidant capacity
Eligibility Criteria
Inclusion Criteria:
- Age 18-35 years
- Three or more recurrent miscarriages before the 24th week of gestation with no apparent cause for their previous losses
- Three or more months have elapsed since the last abortion
- Postmenstrual period
- No other therapy allowed during our treatment course
Exclusion Criteria:
- Concomitant use of organic nitrites, or nitrates
- Severe hepatic, renal, or cardiovascular impairment
- History of stroke or myocardial infarction
- Patients with retinitis pigmentosa.
Sites / Locations
- Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sildenafil citrate
placebo
Arm Description
Outcomes
Primary Outcome Measures
Uterine arteries blood flow
Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index
Secondary Outcome Measures
Nitric oxide serum level as a marked of oxidative stress
Total antioxidant capacity serum level as a marker of oxidative stress
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01419392
Brief Title
Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages
Official Title
Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether sildenafil citrate is effective in improving uterine artery blood flow and oxidative stress in patients with unexplained recurrent miscarriages
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Miscarriage
Keywords
sildenafil citrate, Doppler Ultrasonography, nitric oxide, total antioxidant capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil citrate
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sildenafil citrate
Other Intervention Name(s)
Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt
Intervention Description
25 mg orally, 4 times per day for 21 days
Intervention Type
Drug
Intervention Name(s)
matching placebo
Other Intervention Name(s)
placebo
Intervention Description
orally, 4 times per day for 21 days
Primary Outcome Measure Information:
Title
Uterine arteries blood flow
Description
Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Nitric oxide serum level as a marked of oxidative stress
Time Frame
21 days
Title
Total antioxidant capacity serum level as a marker of oxidative stress
Time Frame
21 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-35 years
Three or more recurrent miscarriages before the 24th week of gestation with no apparent cause for their previous losses
Three or more months have elapsed since the last abortion
Postmenstrual period
No other therapy allowed during our treatment course
Exclusion Criteria:
Concomitant use of organic nitrites, or nitrates
Severe hepatic, renal, or cardiovascular impairment
History of stroke or myocardial infarction
Patients with retinitis pigmentosa.
Facility Information:
Facility Name
Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages
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