search
Back to results

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

Primary Purpose

Asymptomatic Bacteriuria in Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video instructions
Sponsored by
St. Luke's Hospital, Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asymptomatic Bacteriuria in Pregnancy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Verbal Instruction on Urine collection

    Video instruction on urine collection

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Percentage of contaminated urine specimen
    Urines that are contaminated after undergoing culture

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2018
    Last Updated
    August 31, 2018
    Sponsor
    St. Luke's Hospital, Pennsylvania
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03658356
    Brief Title
    Video Instruction in the Collection of Clean Catch Urine in Pregnant Women Undergoing Testing for Urine Culture
    Official Title
    Comparison of Verbal Versus Video Instruction in the Collection of Clean Catch Urine in Pregnant Women Undergoing Testing for Asymptomatic Bacturia: Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 30, 2018 (Anticipated)
    Primary Completion Date
    September 30, 2019 (Anticipated)
    Study Completion Date
    November 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Luke's Hospital, Pennsylvania

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Introduction Asymptomatic bacteriuria (ABU) is defined as the presence of bacteria ( ≥105 per ml) in a non- contaminated urine sample collected from a patient without signs or symptoms related to UTI[1]. Although this is a benign condition that does not require treatment in most adults, ABU in pregnant women has been linked to several complications. The pregnancy state, with its increase in urine stasis and altered immune, can result in increased rates of pyelonephritis and preterm labor[2]. 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[4]. 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[5, 6]. 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. Hypothesis/Clinical Question 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. Material and Methods: All patients (16 years and older) presenting for initial routine prenatal care at one of the St Luke University Hospital perinatal clinics will be eligible. Patients with known urinary infection, symptoms of UTI, and other renal disease will be excluded. Consented patients will be randomized (1:1) using previously prepared sealed envelopes to either the current standard of verbal explanation of the clean-catch urine technique or to view the instructional video on the collection technique. A Spanish version video tape will also be available. These sample results as well as basic patient demographics will be collected (Age, Gestational age, BMI, gravidity, parity) will be compared. We will recruit 200 patients based on an improvement from 15% contaminated rate to a 5% contaminated rate (power 0.80; p=0.05). We will compare proportion of contaminated urine specimens using chi square test to those patients that watch the video to those that did not. In addition, we will compare demographics to determine if any difference exists between the groups. We will employ t-test, chi-squared and Mann-Whitney-U test as appropriate. Risk and cost to patients This study does not incur any additional risk to the patient. No additional cost will be charged to the patients since all pregnant patients receive a urine culture screen as part of their standard of care. Trautner, B.W., Asymptomatic bacteriuria: when the treatment is worse than the disease. Nat Rev Urol, 2011. 9(2): p. 85-93. Glaser, A.P. and A.J. Schaeffer, Urinary Tract Infection and Bacteriuria in Pregnancy. Urol Clin North Am, 2015. 42(4): p. 547-60. Schneeberger, C., B.M. Kazemier, and S.E. Geerlings, Asymptomatic bacteriuria and urinary tract infections in special patient groups: women with diabetes mellitus and pregnant women. Curr Opin Infect Dis, 2014. 27(1): p. 108-14. Patterson, T.F. and V.T. Andriole, Bacteriuria in pregnancy. Infect Dis Clin North Am, 1987. 1(4): p. 807-22. Rogozinska, E., et al., Accuracy of Onsite Tests to Detect Asymptomatic Bacteriuria in Pregnancy: A Systematic Review and Meta-analysis. Obstet Gynecol, 2016. 128(3): p. 495-503. Awonuga, D.O., et al., Asymptomatic bacteriuria in pregnancy: evaluation of reagent strips in comparison to microbiological culture. Afr J Med Med Sci, 2011. 40(4): p. 377-83. Angelescu, K., et al., Benefits and harms of screening for and treatment of asymptomatic bacteriuria in pregnancy: a systematic review. BMC Pregnancy Childbirth, 2016. 16(1): p. 336.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asymptomatic Bacteriuria in Pregnancy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Verbal Instruction on Urine collection
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Arm Title
    Video instruction on urine collection
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Video instructions
    Intervention Description
    Pregnant patient will watch her video explaining how to collect a urine sample for asymptomatic bacteriuria determination.
    Primary Outcome Measure Information:
    Title
    Percentage of contaminated urine specimen
    Description
    Urines that are contaminated after undergoing culture
    Time Frame
    30 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: women that are pregnan and requiring a urine sample for asymptomatic bacteriuria testing Exclusion Criteria: any urinary renal disease, including urinary tract infection, proteinuria, hematuria.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    James N Anasti, MD
    Phone
    484-526-8878
    Email
    anastij@slhn.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs