NCT03319498终止不适用
Postpartum Urinary Retention With Essential Oils (PURE): A Randomized Control Trial of Essential Oil Vapor to Reduce Urinary Catheterization in Postpartum Women
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Resolution of Postpartum Urinary Retention
研究概览
简要总结
The purpose of this study is to examine the effectiveness of peppermint oil to promote voiding and reduce urinary catheterization among postpartum women.
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
- Double (Participant, Care Provider)
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
- •postpartum patients at Mount Carmel East, Mount Carmel West, and Mount Carmel St. Ann's Hospital
- •18 years or older
- •able to read and understand English
- •unable to spontaneously void within 6 hours after vaginal delivery or within 6 hours after straight catheter or within 6 hours after catheter removal for cesarean delivery.
排除标准
- •patients who have an allergy to peppermint oil
- •patients who have asthma
- •patients who report sensitivity to smells
- •patients who have a clinical condition which precludes walking/use of standard toilet
研究组 & 干预措施
Mineral Oil Vapor
Placebo Comparator
Exposure of the perineum to the vapor of the placebo comparator, 2 ml mineral oil. The perineum will NOT come into contact with the oil directly.
干预措施: Mineral Oil Vapor (Other)
Peppermint Oil Vapor
Active Comparator
Exposure of the perineum to the vapor of the active comparator, 2 ml peppermint oil. The perineum will NOT come into contact with the oil directly.
干预措施: Peppermint Oil Vapor (Other)
结局指标
主要结局
Resolution of Postpartum Urinary Retention
时间窗: within 10 minutes after administering study intervention
Spontaneous bladder voiding of at least 150 milliliters
次要结局
- Time to resolution of urinary retention(Within 6 hours of postpartum urinary retention)
- Volume of urine voided(Within 6 hours of postpartum urinary retention)
- Patient Satisfaction Level(Within one hour of study intervention administration)
研究者
Robin Driver
Principal Investigator
Mount Carmel Health System
研究点 (1)
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