Effect of Standardization of Urine Collection Using PEEZY Device as

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05554081
Study type	Interventional
Source	Loyola University
Contact	Ann K Lal, MD
Phone	708-216-5439
Email	ann.lal@lumc.edu
Status	Recruiting
Phase	Phase 3
Start date	August 1, 2022
Completion date	December 31, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms