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
About this trial
This is an interventional diagnostic trial for Asymptomatic Bacteriuria in Pregnancy
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.
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
NCT ID
NCT03658356
First Posted
August 31, 2018
Last Updated
August 31, 2018
Sponsor
St. Luke's Hospital, Pennsylvania
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
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