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

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.

NCT Number	NCT05554081
Lead Sponsor	Loyola University
Conditions	Asymptomatic Bacteriuria, Urinary Tract Infections
Enrollment	200 participants
Start Date	2022-08-01
Primary Completion	2024-01-01 (estimated)
Study Completion	2024-10-31 (estimated)
Updated on ClinicalTrials.gov	2024-10-09