Effect of Standardization of Urine Collection Using PEEZY Device as Compared to Clean Peezy for DAB

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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. 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. Urine specimens will be handed to LOC nursing staff who will separate into 3 aliquots - 1 for clinical lab and 2 for Wolfe lab. 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 Clinical lab specimen will be labeled with patient label and transported to clinical lab for standard urine culture per routine obstetric care.

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

Conditions
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Asymptomatic Bacteriuria, Urinary Tract Infections

Intervention / Treatment
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* Device: Peezy urine collection device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant < 20 weeks gestational age Age > 18 years old English speaking Exclusion Criteria: History of recurrent UTIs Need for ongoing antibiotics Urinary tract anomalies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Clean catch BMI < 30<br>Standard of care urine collection | Device: Peezy urine collection device<br>* use peezy collection to obtain urine sample<br>|
| Placebo Comparator: Clean catch BMI > 30<br>Standard of care urine collection | Device: Peezy urine collection device<br>* use peezy collection to obtain urine sample<br>|
| Experimental: PEEZy collection BMI < 30<br>PEEZY device for urine collection | Device: Peezy urine collection device<br>* use peezy collection to obtain urine sample<br>|
| Experimental: PEEZY collection BMI > 30<br>PEEZY device for urine collection | Device: Peezy urine collection device<br>* use peezy collection to obtain urine sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine contamination rates | 1. To compare the rates of contaminants between CC and PEEZY samples stratified by BMI status (i.e., BMI < 30 and BMI ≥30) | August 2022-August 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal comorbidities and contamination | To compare the rates of contamination based on maternal medical comorbidities | August 2022-August 2023 |