Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies: a Prospective Randomized Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
干预措施: Placebo control (Drug)
PETN
Pentalong, Actavis Germay: 80 mg twice a day
干预措施: PETN (Drug)
结局指标
主要结局
Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile
时间窗: 19 -40 weeks of gestation
次要结局
- Development of IUGR and severe IUGR defined as birth weight below the 5th percentile(19-40 weeks of gestation)
- Preterm birth before completed 37 weeks of gestation and very early preterm birth before completed 32 weeks of gestation(19 - 32 weeks of gestation)
- Development of preeclampsia(19 - 40 weeks of gestation)
- Any form of placental abruption(19 - 40 weeks of gestation)