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临床试验/NCT01419392
NCT01419392Unknown4 期

Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
80
试验地点
1
主要终点
Uterine arteries blood flow

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Concomitant use of organic nitrites, or nitrates
  • Severe hepatic, renal, or cardiovascular impairment
  • History of stroke or myocardial infarction
  • Patients with retinitis pigmentosa.

研究组 & 干预措施

Sildenafil citrate

Experimental

干预措施: Sildenafil citrate (Drug)

placebo

Placebo Comparator

干预措施: matching placebo (Drug)

结局指标

主要结局

Uterine arteries blood flow

时间窗: 21 days

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

次要结局

  • Nitric oxide serum level as a marked of oxidative stress(21 days)
  • Total antioxidant capacity serum level as a marker of oxidative stress(21 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamer El-Refaie

Lecturer of Obstetrics and Gynecology

Ain Shams University

研究点 (1)

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