Effect of Standardization of Urine Collection Using PEEZY Device as Compared to Clean Catch in the Detection of Asymptomatic Bacteriuria in an Obstetric Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Urine contamination rates
研究概览
简要总结
This study aims specifically to compare the rates of contaminants between standard clean-catch urine collection and urine collected using the PEEZY device. In particular, this study will compare the rates of contamination as stratified by BMI status (i.e., BMI < 30 and BMI ≥30). Based on previous studies through LUHS and the Wolfe lab, we anticipate a reduction in contamination from sample collected using the PEEZY device, particularly among those pregnant women with BMI ≥30. To investigate this hypothesis we have designed a prospective unblinded randomized controlled trial comparing voided urine specimens obtained for asymptomatic bacteriuria in pregnant women presenting for obstetric care with use of standard clean-catch (CC) sampling method versus specimen obtained using PEEZY collection device.
详细描述
Recruitment procedures
- All patients scheduled for "NOB" (new obstetrics) appointments at LOC will be screened for eligibility by residents and fellows
- Residents and fellows will recruit participants at LOC and obtain informed consent.
- There will not be any advertising for this study and no recruitment materials will be given to eligible participants.
Study procedures 4. Residents and fellows will use a REDCaps database to assign randomization, generate de-identified study labels, and provide study participants with assigned urine collection device as well as instructions on use. 5. Participants will use a private bathroom to void and collect their urine specimen using either the PEEZY device or standard clean catch method as assigned. 6. Urine specimens will be handed to LOC nursing staff who will separate into 3 aliquots - 1 for clinical lab and 2 for Wolfe lab. 7. Wolfe lab aliquots will be labeled with the subject's study ID and placed at 4°C for <4 hours before transport to Dr. Wolfe's laboratory for inventory, storage and analysis 8. Clinical lab specimen will be labeled with patient label and transported to clinical lab for standard urine culture per routine obstetric care.
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
- 是
入选标准
- •Pregnant < 20 weeks gestational age
- •Age > 18 years old
- •English speaking
排除标准
- •History of recurrent UTIs
- •Need for ongoing antibiotics
- •Urinary tract anomalies
结局指标
主要结局
Urine contamination rates
时间窗: August 2022-August 2023
1. To compare the rates of contaminants between CC and PEEZY samples stratified by BMI status (i.e., BMI \< 30 and BMI ≥30)
次要结局
- Maternal comorbidities and contamination(August 2022-August 2023)
研究者
ann.lal
Assistant Professor
Loyola University
