Effect of Standardization of Urine Collection Using PEEZY Device as Compared to Clean Peezy for DAB
Peezy-DAB
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 21, 2022
CompletedFirst Posted
Study publicly available on registry
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedOctober 9, 2024
October 1, 2024
1.4 years
September 21, 2022
October 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Maternal comorbidities and contamination
August 2022-August 2023
Study Arms (4)
Clean catch BMI < 30
PLACEBO COMPARATORStandard of care urine collection
Clean catch BMI > 30
PLACEBO COMPARATORStandard of care urine collection
PEEZy collection BMI < 30
EXPERIMENTALPEEZY device for urine collection
PEEZY collection BMI > 30
EXPERIMENTALPEEZY device for urine collection
Interventions
use peezy collection to obtain urine sample
Eligibility Criteria
You may qualify if:
- Pregnant \< 20 weeks gestational age
- Age \> 18 years old
- English speaking
You may not qualify if:
- History of recurrent UTIs
- Need for ongoing antibiotics
- Urinary tract anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loyola University medical Center
Maywood, Illinois, 60153, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 21, 2022
First Posted
September 26, 2022
Study Start
August 1, 2022
Primary Completion
January 1, 2024
Study Completion
October 31, 2024
Last Updated
October 9, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share