Expectant Management of Severe Preeclampsia at 28 to 33 Week's Gestation:a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 8
- 主要终点
- Perinatal death
研究概览
简要总结
How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. The interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.
The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.
详细描述
Severa Preeclampsia between 28 and 33 weeks of gestation Women and fetus with stable condition All women receive complete dosis of steroids
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnancy with severe preeclampsia and 28 to 33 weeks of gestation
排除标准
- •Uncontrollable blood pressure or persistent severe hypertension (160/110 mmHg)
- •Persistent symptoms of preeclampsia
- •Maternal complications (HELLP syndrome, acute renal insufficiency, cerebral edema, eclampsia, pulmonary edema)
- •Fetal death, restriction of fetal grown
结局指标
主要结局
Perinatal death
时间窗: After begining the randomization until 4 weeks after delivery.
Number of perinatal in each group (interventionist or expectant management)
次要结局
- Perinatal complications and maternal complications(Maternal and perinatal complication after begining the randomization until 4 weeks after delivery.)
研究者
Paulino Vigil-De Gracia
Paulino Emilio Vigil De Gracia
Complejo Hospitalario Dr. Arnulfo Arias Madrid