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 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.
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.
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 →St. Luke's Hospital, Pennsylvania is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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
Pregnant patient will watch her video explaining how to collect a urine sample for asymptomatic bacteriuria determination.
Percentage of contaminated urine specimen
Urines that are contaminated after undergoing culture
Time frame: 30 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2018; primary completion for Sep 2019, 12 months later.
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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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St. Luke's Hospital, Pennsylvania