Study of Obstetric Foley Therapy (SOFT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Time to Delivery (by Any Route)
研究概览
简要总结
The goal of this study is to compare two clinically-relevant bladder drainage techniques. This is a randomized controlled trial with a single primary outcome of time to delivery. The results will inform clinical decisions about method of catheterization during labor.
详细描述
Urinary catheterization is a common practice during labor following placement of an epidural for pain control, as this form of anesthesia is known to inhibit normal bladder emptying. There is insufficient evidence to guide clinicians in selection of an indwelling catheter versus intermittent straight catheterization during the course of labor.
The goal of this randomized control trial is to compare two clinically-relevant bladder drainage techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Women who present to either Loyola University Medical Center or Loyola at Gottlieb Hospital in active labor or for induction of labor with a singleton pregnancy and who are anticipated to undergo vaginal delivery during the current admission
排除标准
- •Women who are undergoing a scheduled cesarean delivery
- •Women with a contraindication to either of the 2 study interventions
- •Multi-fetal gestations
- •Current or planned tocolysis
- •Women who are on magnesium prophylaxis
结局指标
主要结局
Time to Delivery (by Any Route)
时间窗: 1 day
Time to delivery defined as IV placement to delivery of infant.
次要结局
- Difference in Cost Between the Two Interventions(End of study.)