Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- improvement of the Doppler indices following treatment
研究概览
简要总结
To detect the effect of sildenafil citrate on Doppler parameters in fetuses suffering from growth restriction to support its use later as prolonged therapy in those pregnancies at higher risk for such complication.
详细描述
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.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients were admitted to the study based on the following inclusion criteria:
- •Any age and any party.
- •Body mass index between 25 and
- •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 .
排除标准
- •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
研究组 & 干预措施
sildenafil citrate
50 mg single oral dose
干预措施: sildenafil citrate (Drug)
placebo
single tablet of placebo
干预措施: placebo (Other)
结局指标
主要结局
improvement of the Doppler indices following treatment
时间窗: 9 months
次要结局
未报告次要终点