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

Status: Active_not_recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• Pregnant \< 20 weeks gestational age

• Age \> 18 years old

• English speaking

Locations
United States
Illinois
Loyola University medical Center
Maywood
Time Frame
Start Date: 2022-08-01
Completion Date: 2024-10-31
Participants
Target number of participants: 200
Treatments
Placebo_comparator: Clean catch BMI < 30
Standard of care urine collection
Placebo_comparator: Clean catch BMI > 30
Standard of care urine collection
Experimental: PEEZy collection BMI < 30
PEEZY device for urine collection
Experimental: PEEZY collection BMI > 30
PEEZY device for urine collection
Sponsors
Leads: Loyola University

This content was sourced from clinicaltrials.gov