Video Instruction in the Collection of Clean Catch Urine in Pregnant Women Undergoing Testing for Urine Culture

NCT03658356 | Unknown

• 1 other identifier: SLIR 2018-89
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The prevalence of asymptomatic bacteriuria in pregnancy has been reported in the range of 2-15%\[3\]. Due to the severity of the complications related to asymptomatic bacteriuria in this patient population, the American College of OBGYN recommends routine screening of all pregnant women. Asymptomatic bacteriuria in a pregnant woman should be screened only using a clean-catch non contaminated urine sample. Screening for ABU using urine chemistries is not recommended due to the lack of sensitivity and specificity of these tests . If ABU is present, appropriate antibiotic is given and post treatment urine culture is performed. However, a controversy does exist as to the value of treatment of ABU in the prevention of above noted complications \[7\]. Interestingly, we have noted a contaminated urine cultures in up to 15 to 20% of our prenatal patients. This can be frustrating to both the patient and her physician. Repeat testing, delay in the diagnosis, and additional cost are just some of the problems associated with these contaminated urine cultures. We hypothesis by improving the instructions given to patients on how to perform a clean catch urine, that we will decease our contaminated urine cultures.

Conditions

Asymptomatic Bacteriuria in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Percentage of contaminated urine specimen

  Urines that are contaminated after undergoing culture

  30 days

Study Arms (2)

Verbal Instruction on Urine collection

PLACEBO COMPARATOR

At initial prenatal visit, pregnant patients will be given verbal instructions on how to collect a urinary sample for culture. Intervention: Pt will be given verbal instruction to collect urine

Other: Video instructions

Video instruction on urine collection

ACTIVE COMPARATOR

At initial prenatal visit, pregnant patients will watch a video on how to collect a urinary sample for culture Intervention: Patient will be asked to watch a video on how to collect a urine sample

Other: Video instructions

Interventions

Video instructions OTHER

Pregnant patient will watch her video explaining how to collect a urine sample for asymptomatic bacteriuria determination.

Verbal Instruction on Urine collection; Video instruction on urine collection

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• women that are pregnan and requiring a urine sample for asymptomatic bacteriuria testing

You may not qualify if:

• any urinary renal disease, including urinary tract infection, proteinuria, hematuria.

Sponsors & Collaborators

• St. Luke's Hospital, Pennsylvania: lead

Central Study Contacts

James N Anasti, MD

CONTACT

484-526-8878; anastij@slhn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor OB/GYN

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 5, 2018
• Study Start: September 30, 2018
• Primary Completion: September 30, 2019
• Study Completion: November 30, 2019
• Last Updated: September 5, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share