Evaluation of Addition of Sildenafil Citrate for Treatment of Severe Intrauterine Growth Restriction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Middle cerebral artery Pulsatility index
研究概览
简要总结
Severe fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and mortality.Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies.
详细描述
The aim of our study is to evaluate the effect of sildenafil citrate therapy on severe early and late onset intrauterine growth retardation.A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a prospective case control study .
Patients will randomly be allocated to two groups with 23 patients in each group.Sildenafil citrate therapy may increase the likelihood of increased growth velocity [measured by abdominal circumference (AC) (ultrasound)] for fetuses of pregnancies complicated by severe early-onset IUGR .Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP which results in increased levels of cGMP, leading to smooth muscle relaxation. Placental disease, consequent on deficient uteroplacental blood flow, includes FGR, pre-eclampsia, and placental abruption and has been implicated in more than 50% of iatrogenic premature births .For this reason, the problem of severe FGR forms a substantial portion of the population that tertiary care centres care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Patients will randomly be allocated to two groups with 23 patients in each group
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnancy complicated by severe IUGR [abdominal circumference (AC)< 5th percentile] the gestational age <25 weeks or an estimate of the fetal weight was <600 gm (excluding known fetal anomaly/syndrome and/or planned termination) ( von Dadelszen.et al;2011).
排除标准
- •known aneuploid anomaly, syndrome congenital infection.
- •If there is a plan to terminate the pregnancy.
研究组 & 干预措施
Intervention group
women with severe IUGR
干预措施: treatment (Other)
Control group
women with severe IUGR
干预措施: Placebo (Other)
结局指标
主要结局
Middle cerebral artery Pulsatility index
时间窗: between 24 gestational weeks until 36 weeks
Change in middle cerebral artery pulsatility index after medication
fetal abdominal circumference growth velocity
时间窗: between 24 gestational weeks until 36 weeks
proportion of women in each group for whom fetal AC growth velocity will change post randomization.
Umbilical artery Pulsatility index
时间窗: between 24 gestational weeks until 36 weeks
Change in umbilical artery pulsatility index after medication
次要结局
- Rate of drug side effects(between 24 and 36 gestational weeks)
- Birth weight(between 24 and 36 gestational weeks)
研究者
Nesreen Abdel Fattah Abdullah Shehata
Assistant Professor of Obstetrics and Gynecology
Beni-Suef University