NCT03177824Unknown3 期
Sildenafil Citrate for Treatment of Growth-restricted Fetuses
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- date of delivery after Sildenafil citrate administration.
研究概览
简要总结
The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age ranging from 20-40 years.
- •Gestational age 28-37 weeks.
排除标准
- •Obese patients (BMI >30 kg/m2).
- •Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss.
- •Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin.
- •Fetal distress.
- •Pregnancy of multiple fetuses.
- •Congenital fetal malformation or chromosomal abnormalities.
- •Diastolic blood pressure more than 110 mmHg.
- •Hypersensitivity to the drug.
研究组 & 干预措施
S
Experimental
Sildenafil citrate (25mg)
干预措施: Sildenafil Citrate 25Mg Tab (Drug)
P
Placebo Comparator
placebo oral tablet
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
date of delivery after Sildenafil citrate administration.
时间窗: for 6 months from the beginning of the study
the study aims to assess date of delivery of growth restricted fetus after administration of sildenafil citrate by dose of 20mg three times per day , and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
次要结局
- neonatal outcomes as regard birth weight(for 6 months from the beginning of the study)
- Expected fetal weight by serial ultrasound after Sildenafil citrate administration(every two weeks after drug intake for 6 months from the beginning of the study)
- Color Doppler changes on umbilical artery(weekly after drug intake for 6 months from the beginning of the study)
- neonatal outcomes as regard APGAR score(for 6 months from the beginning of the study)
研究者
Shaimaa Mohamed Ezz el din
resident of obstetrics and gynecology
Ain Shams University
研究点 (1)
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