Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Neonatal birth weight in grams
研究概览
简要总结
comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due to placental insufficiency
详细描述
One hundred pregnant women with documented intrauterine growth restriction due to placental insufficiency at 28-35 weeks of gestation will be distributed into two groups:
- Group S: 50 women will receive Sildenafil citrate 25 mg tab 3 times daily.
- Group H: 50 women will receive single dose of LMWH subcutaneous daily.
Both groups will undergo strict fetal surveillance in the form of:
Umbilical artery Doppler (UAD) is the primary surveillance tool in the FGR fetus:
middle cerebral artery (MCA) Doppler, ultrasound for (AC, EFW, and deepest vertical pocket (DVP) for amniotic fluid) and non stress test and Biophysical profile (BPP)
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
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age between 20-35 years.
- •Being at a gestational age 28-35wks.
- •Singleton pregnancy.
- •Fetal growth restriction diagnosed by ultrasound with estimated fetal weight below the 10th percentile, and/or fetal abdominal circumference at or below the tenth percentile.
排除标准
- •Maternal age less than 20 years or more than 35 years.
- •Undetermined gestational age.
- •Multiple gestation.
- •Chronic diseases with pregnancy e.g. Chronic hypertension, diabetes type 1 or
- •Etiologies of FGR other than placental insufficiency as fetal malformations, aneuploidy or infections.
- •Suspected fetal compromise requiring emergency delivery.
- •Any contraindication to the use of sildenafil e.g. known significant maternal cardiac disease, left ventricular outflow tract obstruction, concomitant treatment with nitrates or previous allergy to sildenafil.
- •Any contraindication to the use of LMWH e.g. known bleeding disorder, active antenatal bleeding or at increased risk of major hemorrhage (e.g. placenta praevia), thrombocytopenia, severe renal or hepatic disease.
- •Drug or alcohol abuse.
- •Patient refusing to participate in the study or unable to consent.
研究组 & 干预措施
sildenafil citrate
50 pregnant female will be treated with sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery.
干预措施: Sildenafil (Drug)
low molecular weight heparin
50 pregnant female will be treated with a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery according to body weight as follow < 50 kg 3500 units daily 50-90 kg 4500 units daily 91-130 kg 7000 units daily 131-170 kg 9000 units daily > 170 kg 75 u/kg/day
干预措施: low molecular weight heparin (Drug)
结局指标
主要结局
Neonatal birth weight in grams
时间窗: At time of Delivery
次要结局
- APGAR score(at 1 and 5 min of life)
- The change in Doppler velocity indices,(24 week till 35 weeks)
- Fetal growth velocity(weekly till time of delivery)
- Gestational age at delivery,(at time of delivery)
- Neonatal complication rates(The first 28 day of delivery)
- Neonatal ICU admission rate(The first 28 day of delivery)
- the interval between the diagnosis and delivery(at time of delivery)
研究者
Radwa Rasheedy Ali
lecturer of obstetrics and gynecology
Ain Shams University