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Active, Not Recruiting

NCT Number: NCT05554081

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Asymptomatic Bacteriuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University medical Center

Maywood, Illinois, 60153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peezy urine collection device

Device

use peezy collection to obtain urine sample

Primary outcomes

  1. Urine contamination rates

    Time frame: August 2022-August 2023

    • To compare the rates of contaminants between CC and PEEZY samples stratified by BMI status (i.e., BMI < 30 and BMI ≥30)

Secondary outcomes

  1. Maternal comorbidities and contamination

    Time frame: August 2022-August 2023

    To compare the rates of contamination based on maternal medical comorbidities

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

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

Acronym: Peezy-DAB

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2022
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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