Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

Phase 4UnknownNCT01419392

Ain Shams University80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Recurrent Miscarriage

Interventions

Sildenafil citrateDRUG

25 mg orally, 4 times per day for 21 days

matching placeboDRUG

orally, 4 times per day for 21 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

Uterine arteries blood flow

Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index

Time frame: 21 days

Secondary Outcomes

Nitric oxide serum level as a marked of oxidative stress

Time frame: 21 days

Total antioxidant capacity serum level as a marker of oxidative stress

Time frame: 21 days

Data from ClinicalTrials.gov

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