Multicenter Study on Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15,926
- 试验地点
- 6
- 主要终点
- the incidence of early-onset neonatal infections
研究概览
简要总结
This study hypothesizes that early-onset neonatal Infections are related to premature rupture of membrane (PROM) and that early intervention can improve the prognosis of newborns. The objective of this study is to analyze the correlation between PROM and early-onset neonatal infections and to assess the prognosis of newborns. A cohort study is designed to implement the study. The subjects of study group are pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks. The subjects of control group are pregnant women without PROM and chorioamnionitis. Control group and research group are paired at 1: 1 ratio. The main contents of the study include three aspects. (1) The correlation between PROM and chorioamnionitis. (2) The correlation between PROM and early-onset neonatal infections. (3) The pathogenesis of intrauterine infection and neonatal infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •PROM or chorioamnionitis
- •gestational age is ≥ 24 weeks
排除标准
- •gestational age <24 weeks
- •artificial rupture of membrane for labor induction
- •natural rupture of membrane during induction before labor
结局指标
主要结局
the incidence of early-onset neonatal infections
时间窗: 7 days after birth
The incidence of early-onset neonatal infections will be compared between study group and control group.
次要结局
未报告次要终点