Sildenafil Citrate for Treatment of Growth-restricted Fetuses
2017年6月8日 更新者：Shaimaa Mohamed Ezz el din、Ain Shams University
The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.
研究概览
研究类型
介入性
注册 (预期的)
60
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Cairo、埃及
- 招聘中
- Ain Shams matrnity hospital
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接触：
- shaimaa mohamed Ezz el Din, MB ChB
- 电话号码：+201000484298
- 邮箱：dr.shaimaaezz666@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 40年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Maternal age ranging from 20-40 years.
- Gestational age 28-37 weeks.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：S
Sildenafil citrate (25mg)
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Group 1, consists of 30 patients who will receive Sildenafil citrate (25mg) tab (Silden, Epico, Egypt) 3times daily till the time of delivery, followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score.
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安慰剂比较：P
placebo oral tablet
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Group 2, consists of 30 patients receiving placebo Oral Tablet 3times daily , followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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date of delivery after Sildenafil citrate administration.
大体时间：for 6 months from the beginning of the study
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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.
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for 6 months from the beginning of the study
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Expected fetal weight by serial ultrasound after Sildenafil citrate administration
大体时间：every two weeks after drug intake for 6 months from the beginning of the study
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the Expected fetal weight in grams by serial ultrasound is assessed in women with growth redistricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
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every two weeks after drug intake for 6 months from the beginning of the study
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Color Doppler changes on umbilical artery
大体时间：weekly after drug intake for 6 months from the beginning of the study
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Color Doppler changes on umbilical artery is assessed in women with growth restricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
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weekly after drug intake for 6 months from the beginning of the study
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neonatal outcomes as regard birth weight
大体时间：for 6 months from the beginning of the study
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the study aims to assess neonatal outcomes as regard, birth weight in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
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for 6 months from the beginning of the study
|
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neonatal outcomes as regard APGAR score
大体时间：for 6 months from the beginning of the study
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the study aims to assess neonatal outcomes as regard APGAR score in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
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for 6 months from the beginning of the study
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月30日
初级完成 (预期的)
2017年9月30日
研究完成 (预期的)
2017年10月1日
研究注册日期
首次提交
2017年4月26日
首先提交符合 QC 标准的
2017年6月5日
首次发布 (实际的)
2017年6月6日
研究记录更新
最后更新发布 (实际的)
2017年6月9日
上次提交的符合 QC 标准的更新
2017年6月8日
最后验证
2017年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.