Is Outpatient Management of PPROM Equivalent to Hospital Management
试验速览
- 阶段
- 不适用
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- rate occurence of Neonatal sepsis
研究概览
简要总结
This study is to compare the maternal and neonatal outcomes in the patients with PPROM who are managed at home versus those managed at hospital, half the patients will be managed at home and the other half will be managed inpatient.
详细描述
Now the current practice is to manage patients with PPROM at hospital, however it is not known yet whether this practice is better than outpatient management as regard maternal and neonatal outcome.
There is some recent evidence that home management of PPROM is safe for both mother and neonate, home management is also more convenient with less expenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PPROM with gestational age between 27 to 34 weeks
- •Cephalic presentation
- •Clear amniotic fluid
- •Oral temperature > 38 C
- •Near distance from the hospital (the patient can reach hospital within one hour )
- •Home environment safe and amenable to rest , availability of family support such as a sister or mother who will help the patient at home .
- •Maternal and fetal condition remain stable after hospitalization for 72 hours
排除标准
- •Patient with equivocal diagnosis of rupture of membranes
- •advanced labor
- •intrauterine infection
- •vaginal bleeding or
- •non reassuring fetal heart rate.
结局指标
主要结局
rate occurence of Neonatal sepsis
时间窗: 48 hours after delivery
proven neonatal infection with positive blood culture within 48 hours after birth, or culture proven neonatal pneumonia or meningitis
次要结局
- rate of occurence of Maternal morbidity(48 hours after delivery)
研究者
dina mostafa ibrahim
specialist
Ain Shams Maternity Hospital