A Comparison of Sterile and Non-sterile Gloves for the Incidence of Chorioamnionitis During Labor: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 507
- 试验地点
- 2
- 主要终点
- Clinical chorioamnionitis
研究概览
简要总结
The purpose of this study is to determine whether the use of sterile or clean gloves during labor exams affects the rate of chorioamnionitis. Chorioamnionitis is an infection of the membranes around the baby.
详细描述
The importance of this study is that intrapartum vaginal exams (while patients are laboring) are performed routinely in modern obstetrical practice, and there is no randomized trial available assessing the relationship between the type of glove used and the rate of chorioamnionitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Spontaneous or induced labor
- •Rupture of membranes < 12 hours
- •Nulliparous or multiparous
- •Gestational age greater than or equal to 34 weeks
- •Age greater than or equal to 18
排除标准
- •Contraindications to labor
- •Multiple gestations
- •Rupture of Membranes greater than 12 hours
- •Gestational age less than 34 weeks
- •Non-English speaking patients
研究组 & 干预措施
Nonsterile
Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.
干预措施: Type of glove used for intrapartum vaginal exams (Other)
Sterile
Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.
干预措施: Type of glove used for intrapartum vaginal exams (Other)
结局指标
主要结局
Clinical chorioamnionitis
时间窗: participants will be followed during their intrapartum hospital stay, an expected average of 48-72hrs
Clinical chorioamnionitis with at least two of the four criteria met-maternal fever of 38 degrees Celsius or greater, maternal tachycardia (pulse \>100), fetal tachycardia (fetal heart rate \>160), and/or fundal tenderness
次要结局
未报告次要终点