跳至主要内容
临床试验/NCT05554081
NCT05554081进行中(未招募)不适用

Effect of Standardization of Urine Collection Using PEEZY Device as Compared to Clean Catch in the Detection of Asymptomatic Bacteriuria in an Obstetric Population

Loyola University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年8月1日最近更新:
适应症

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

  1. All patients scheduled for "NOB" (new obstetrics) appointments at LOC will be screened for eligibility by residents and fellows
  2. Residents and fellows will recruit participants at LOC and obtain informed consent.
  3. 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

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

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ann.lal

Assistant Professor

Loyola University

研究点 (2)

Loading locations...

相似试验