Randomized Double-Blind, Placebo Controlled Evaluation of the Efficacy of Sildenafil Versus Placebo in Preterm Preeclampsia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Latency (duration of pregnancy from diagnosis/randomization until delivery)
研究概览
简要总结
Randomized controlled trial to assess efficacy of Sildenafil in addition to expectant management for the treatment of preterm preeclampsia
详细描述
Preeclampsia is a major cause of maternal mortality. When preeclampsia presents prior to thirty-four weeks of gestation, expectant management is the standard practice in stable patients with the goal of extending pregnancy and therefore decreasing the risk of adverse outcomes in the premature neonate. Our aim was to assess the efficacy of Sildenafil, a phosphodiesterase inhibitor, versus placebo, in addition to expectant management, for the treatment of preterm preeclampsia to prolong pregnancy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients of gestational age of ≥24 0/7 weeks to ≤32 0/7 weeks.
- •Dating of pregnancy by ultrasound < or equal to 22 weeks or IVF conception
- •Diagnosis of Preterm Preeclampsia or Superimposed Preeclampsia
排除标准
- •Need for immediate delivery of the fetus
- •Known lethal anomaly
- •Pre-existing renal disease
- •Hypersensitivity to sildenafil
- •Pre-gestational diabetes, class C (onset prior to 10-19 or duration 10-19 yrs
- •Active peptic ulcer disease
- •Undergoing nitrate therapy
研究组 & 干预措施
Sildenafil
Sildenafil 40mg oral tablet three times a day from randomization until delivery
干预措施: Sildenafil (Drug)
Placebo
Matched to oral capsule of active treatment three times a day from randomization until delivery
干预措施: Sildenafil (Drug)
Placebo
Matched to oral capsule of active treatment three times a day from randomization until delivery
干预措施: Placebo (Drug)
结局指标
主要结局
Latency (duration of pregnancy from diagnosis/randomization until delivery)
时间窗: Diagnosis (randomization) until delivery, up to 34 weeks)
earliest randomization can occur at 24 weeks gestation
次要结局
未报告次要终点