Pomegranate to Reduce Maternal and Fetal Oxidative Stress and to Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of Membranes
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Maternal and fetal oxidative stress
研究概览
简要总结
Preterm premature rupture of membrane is associated with increased oxidative stress and inflammatory process, enhancing the activity or the availability of antioxidants may modulate the inflammatory response associated with PPROM, thereby reducing oxidative stress and the risk to the fetus. In this study the investigators sought to determine the effects of Pomegranate 1. On the patients (maternal and fetal) oxidative stress and inflammation associated with PPROM. 2. On the time interval from PPROM to delivery and on the patients (fetal )Ph and apger scores
详细描述
In this study the investigators sought to determine the effects of Pomegranate 1. On the patients (maternal and fetal )oxidative stress and inflammation associated with PPROM. 2. On the time interval from PPROM to delivery and on the patients (fetal )Ph and apger scores
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
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients
- •admitted with PPROM
- •between 24-32 weeks of gestation
排除标准
- •Women with contractions
- •abruption
- •monochorionic multiple pregnancy
- •abnormal (non-reassuring) cardiotocogram
- •meconium-stained amniotic fluid
- •signs of intrauterine infection
- •major fetal anomalies
- •hemolysis
- •elevated liver enzymes
- •low platelets (HELLP syndrome); or severe preeclampsia.
结局指标
主要结局
Maternal and fetal oxidative stress
时间窗: 10 weeks
Maternal and fetal oxidative stress will be determined by blood tests.
次要结局
- Time interval from PPROM to delivery(10 weeks)
- time interval from PPROM to delivery(10 weeks)