Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies
Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies: a Prospective Randomized Pilot Study
Pregnancies resulting in IUGR and also in preeclampsia are strongly associated with typical underlying placental pathology revealing small placentas and maldevelopment of the decidual blood vessels, suggesting under-perfusion from the maternal circulation. Since nitric oxide (NO) donors can improve decreased uteroplacental perfusion without any negative effects on fetal circulation, these may prevent negative pregnancy outcomes in patients at risk.
The aim of this study is to evaluate the effectiveness of the long-lasting NO donor pentarythrithyltetranitrate (PETN) to reduce the likelihood of adverse pregnancy outcomes (intrauterine growth retardation / IUGR, perinatal death, placental abruption, and preterm delivery) in women recognized to be at risk for this outcome by abnormal uterine flow in mid gestation.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
-
-
Thüringen
-
Jena、Thüringen、德国、07743
- University Hospital Jena, Department of Obstetrics
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- pregnant women 190 to 236 weeks of gestation
- abnormal uterine Doppler as defined by bilateral notching, unilateral notching and increased impedance with mean resistance index (RI) > 0.65 or with mean RI > 0.7 without notching at time of enrollement
- informed consent
Exclusion Criteria:
- multiple gestation
- documented chromosomal or major fetal abnormalities
- rupture of membranes and/or clinical chorioamnionitis at time of enrolment
- maternal disease defined as contraindication for intake of PETN
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:安慰剂
|
orally, twice daily
|
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实验性的:PETN
Pentalong, Actavis Germay: 80 mg twice a day
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Pentaerythrithyltetranitrate: 80 mg orally twice a day
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile
大体时间:19 -40 weeks of gestation
|
19 -40 weeks of gestation
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Development of IUGR and severe IUGR defined as birth weight below the 5th percentile
大体时间:19-40 weeks of gestation
|
19-40 weeks of gestation
|
|
Preterm birth before completed 37 weeks of gestation and very early preterm birth before completed 32 weeks of gestation
大体时间:19 - 32 weeks of gestation
|
19 - 32 weeks of gestation
|
|
Development of preeclampsia
大体时间:19 - 40 weeks of gestation
|
19 - 40 weeks of gestation
|
|
Any form of placental abruption
大体时间:19 - 40 weeks of gestation
|
19 - 40 weeks of gestation
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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