Recurrent Miscarriage Clinical Trial
Official title:
Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial
Verified date | April 2012 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | June 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uterine arteries blood flow | Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index | 21 days | No |
Secondary | Nitric oxide serum level as a marked of oxidative stress | 21 days | No | |
Secondary | Total antioxidant capacity serum level as a marker of oxidative stress | 21 days | No |
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