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Status unknownNCT03658356Updated Sep 5, 2018

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

An interventional study of Video instructions in Asymptomatic Bacteriuria in Pregnancy, sponsored by St. Luke's Hospital, Pennsylvania. Status unknown. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by St. Luke's Hospital, Pennsylvania · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
16 Years and older
Sex
Female
01

Study 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.

Read the 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.

  1. Trautner, B.W., Asymptomatic bacteriuria: when the treatment is worse than the disease. Nat Rev Urol, 2011. 9(2): p. 85-93.
  2. Glaser, A.P. and A.J. Schaeffer, Urinary Tract Infection and Bacteriuria in Pregnancy. Urol Clin North Am, 2015. 42(4): p. 547-60.
  3. 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.
  4. Patterson, T.F. and V.T. Andriole, Bacteriuria in pregnancy. Infect Dis Clin North Am, 1987. 1(4): p. 807-22.
  5. 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.
  6. 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.
  7. 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.
02

Conditions studied

  • Asymptomatic Bacteriuria in Pregnancy

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03

In context

Bacteriuria

51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 37 interventional studies indexed under Bacteriuria.

Browse Bacteriuria studies →

Lead sponsor

St. Luke's Hospital, Pennsylvania is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • any urinary renal disease, including urinary tract infection, proteinuria, hematuria.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Placebo comparator
    Verbal Instruction on Urine collection

    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

  • Active comparator
    Video instruction on urine collection

    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

  • OtherVideo instructions

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

06

What researchers measure

Primary outcomes

  1. Percentage of contaminated urine specimen

    Urines that are contaminated after undergoing culture

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2018; primary completion for Sep 2019, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2018
First posted
Sep 5, 2018
StartEst.
Sep 30, 2018
Primary completionEst.
Sep 30, 2019
CompletionEst.
Nov 30, 2019
Last update
Sep 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03658356
Lead sponsor
St. Luke's Hospital, Pennsylvania
Responsible party
James Anasti, MD (Clinical Professor OB/GYN, St. Luke's Hospital, Pennsylvania) — Principal investigator
First posted
Sep 5, 2018
Start date
Sep 30, 2018 (estimated)
Primary completion
Sep 30, 2019 (estimated)
Completion
Nov 30, 2019 (estimated)
Last update
Sep 5, 2018

Study contacts

James N Anasti, MD
Contact
anastij@slhn.org
484-526-8878

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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