Asymptomatic Bacteriuria in PregnancyNCT03658356
Video Instruction in the Collection of Clean Catch Urine in Pregnant Women Undergoing Testing for Urine Culture
A study testing Video instructions in people with Asymptomatic Bacteriuria in Pregnancy, run by St. Luke's Hospital, Pennsylvania.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Asymptomatic Bacteriuria in Pregnancy
- What is being tested?
- Video instructions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women that are pregnan and requiring a urine sample for asymptomatic bacteriuria testing
Who cannot join
- any urinary renal disease, including urinary tract infection, proteinuria, hematuria.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- 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.
- Conditions
- Asymptomatic Bacteriuria in Pregnancy
- Being tested
- Video instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video instructionsOther
Pregnant patient will watch her video explaining how to collect a urine sample for asymptomatic bacteriuria determination.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Video instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of contaminated urine specimen
Urines that are contaminated after undergoing culture
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start30 Sep 2018 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Bacteriuria in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Anasti, MD, St. Luke's Hospital, Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658356
- Sponsor's protocol ID
- SLIR 2018-89
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03658356
- Acronym / sponsor ID
- SLIR 2018-89
- Conditions
- Asymptomatic Bacteriuria in Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- 30 Sep 2018 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verbal Instruction on Urine collection | Placebo comparator | Other: Video instructionsAt 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 |
| Video instruction on urine collection | Active comparator | Other: Video instructionsAt 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- women that are pregnan and requiring a urine sample for asymptomatic bacteriuria testing
Key exclusion criteria (1 listed)
- any urinary renal disease, including urinary tract infection, proteinuria, hematuria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video instructionsPregnant patient will watch her video explaining how to collect a urine sample for asymptomatic bacteriuria determination. | Other | Verbal Instruction on Urine collection, Video instruction on urine collection |
Primary outcome
Percentage of contaminated urine specimen
Time frame: 30 days
Urines that are contaminated after undergoing culture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Video instructions in people with Asymptomatic Bacteriuria in Pregnancy, run by St. Luke's Hospital, Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James N Anasti, MD (484-526-8878, anastij@slhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of contaminated urine specimen (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.