A Randomized Controlled Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The change in Doppler velocity indices( Resistance index (RI) and the pulsatility index (PI) of the umbilical arteries as a Ratio
研究概览
简要总结
This is a Randomized Controlled Trial to evaluate the effect of sildenafil on Doppler velocity indices of the umbilical arteries in patients with placental insufficiency and fetal growth restriction, and if sildenafil can improve fetal and neonatal outcomes in those patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women, singleton pregnancy, gestational age 24-34 weeks, with
- •Fetal growth restriction.
- •Intact membranes.
- •Abnormal umbilical artery Doppler waveforms.
- •Fetal abdominal circumference at or below the tenth percentile.
- •Normal venous fetal Doppler
排除标准
- •Undetermined gestational age.
- •Intrauterine infection.
- •High Risk for aneuploidy (e.g. maternal age ≥40 years, detected congenital fetal anomalies in the current or previous pregnancies).
- •Maternal cardiovascular morbidity.
- •Users of any vasodilator agents.
- •Known allergy to sildenafil citrate
研究组 & 干预措施
sildenafil citrate
Group A (45 patients): pregnancies affected by Fetal Growth Restriction (FGR) being treated with sildenafil citrate 25 mg of sildenafil citrate every 8 hours starting at diagnosis of FGR until delivery
干预措施: Sildenafil citrate (Drug)
placebo
Group B (45 patients): pregnancies affected by Fetal Growth Restriction (FGR) being treated with placebo every 8 hours starting at diagnosis of FGR until delivery.
干预措施: placebo (Drug)
结局指标
主要结局
The change in Doppler velocity indices( Resistance index (RI) and the pulsatility index (PI) of the umbilical arteries as a Ratio
时间窗: 24 weeks to 34 weeks of gestation.
The change in Doppler velocity indices( Resistance index (RI) and the pulsatility index (PI), of fetal middle cerebral artery as a Ratio
时间窗: 24 weeks to 34 weeks of gestation.
次要结局
- Neonatal complication rates including Intraventricular hemorrhage (IVH) , Neonatal Necrotizing Enterocolitis (NEC) , Syndrome Respiratory Distress (RDS) , Neonatal anemia, Neonatal blood transfusion).(The first 28 day of delivery)
- Neonatal ICU admission rate(The first 28 day of delivery)
- Neonatal birth weight in grams(At time of Delivery)
- Gestational age at delivery in weeks(At time of Delivery)
研究者
Ahmed Abdel Shafy El Shahawy
Lecturer
Ain Shams University