S100B as a Marker for Fetal Brain Injury in Premature Rupture of Membranes
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Developmental assessment
研究概览
简要总结
Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus. Fetus' brain is highly vulnerable and could be harmed even by mild inflammation before fulminant infection is developed. The aim of this study is to identify, as early as, possible signs of brain injury. S100B protein will be used as a marker for brain insult. S100b level were associated with the occurrence and size of stroke and brain trauma in adults and children. Moreover, S100B crosses the membrane and its level in women with preterm labor was associated with brain injury of preterm infant.
The study question is whether the levels of S100B in women with early amniotic fluids breakdown are associated with future brain injury of the infant, as assessed by head ultrasound and neurological examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Rupture of the amniotic sac before 32 weeks
- •Gestational age less than 32 weeks
- •Singleton
排除标准
- •Intrauterine growth restriction
- •Positive TORCH
- •Fetus' brain malformation
- •Fetus' brain hemorrhage
- •Maternal medication with teratogenic effect
结局指标
主要结局
Developmental assessment
时间窗: 3 month
Developmental assessment at term and 3 month 1. Neurological examination 2. Test of infant motor performance
次要结局
未报告次要终点