Screening For Urinary Tract Infection Research Articles

Recent Studies on the Care of First Febrile Urinary Tract Infection in Infants and Children for the Pediatric Hospitalist.

Urinary Tract Infection (UTI) is a common cause of bacterial infection in young children, and accounts for a significant number of pediatric hospitalizations. To review recent publications focusing on the care of children hospitalized with their first febrile UTI. A PubMed search was performed including publications from 2011-2016 on first febrile UTI in childhood. Abstracts were reviewed for being relevant to the care of hospitalized children and their follow-up. Relevant articles underwent full review by all authors and articles excluded from results included those without novel data analysis, primary improvement-based reports and studies with poor design or analysis. Included articles were categorized as "diagnosis", "management", "imaging" or "follow-up". Of 406 articles initially identified, 40 studies were included. One technical report with a systematic review was also included. Major topics addressed included the role of urinalysis in screening for UTI, use of parenteral antimicrobial therapy, the role of antimicrobial prophylaxis in prevention of recurrent UTI, and ideal follow-up and imaging approach following diagnosis of febrile UTI. Recent literature on first febrile UTI addresses a broad range of areas regarding the care of hospitalized children, though some questions remain unanswered. Overall, studies support increased attention to the potential risks, expense and invasiveness of various approaches for evaluation. Proposed updates to practice included: utilization of urinalysis for screening and diagnosis, transitioning to oral antimicrobials based on clinical improvement and limiting the routine use of voiding cystourethrogram and antimicrobial prophylaxis.

Evaluation of the application of urinary tract infection and bacterial information parameters in the screening of urinary tract infections

Evaluation of the application of urinary tract infection and bacterial information parameters in the screening of urinary tract infections

Evaluation of the Cobas u 701 microscopy analyser compared with urine culture in screening for urinary tract infection.

Purpose. A new automated Cobas u 701 microscopy analyser for urine sediment examination was introduced. The aim of this study was to evaluate the analyser in comparison with urine culture in screening for urinary tract infection (UTI).Methodology. A total of 852 urine specimens submitted for culture were included in this study. Urine sediment examination was performed using the Cobas u 701 microscopy analyser. The results of the bacteria (BAC) and yeast (YEA) analyses were compared with the results from urine culture as a method for UTI screening. In addition, we compared the BAC results with white blood cells (WBCs) and leukocyte and nitrite measurement in the Cobas u 601 system.Results. Of the 852 urine specimens, 16.1 % (N=137) were positive by urine culture, yielding 130 bacteria from 124 specimens and 14 yeasts from 14 specimens. The Cobas u 701 microscopy analyser provided no result for 52 specimens because of their high turbidity. The sensitivity, specificity, positive predictive value and negative predictive value were 85.8, 69.4, 33.1 and 96.5 %, respectively. For YEA, these figures were 100, 91.9, 15.8 and 100 %, respectively. The areas under the curve for BAC and WBCs were 0.827 [95 % confidence interval (CI) 0.799, 0.852] and 0.727 (95 % CI 0.695, 0.757), respectively. The sensitivity of the leukocyte and nitrite was 63.5 and 54.6 %, respectively.Conclusion. The Cobas u 701 microscopy analyser showed good diagnostic performance. It can be used for rapid screening for UTI and can reduce the number of cultures required.

Microfluidic Capillaric Circuit for Rapid and Facile Bacteria Detection.

Urinary tract infections (UTI) are one of the most common bacterial infections and would greatly benefit from a rapid point-of-care diagnostic test. Although significant progress has been made in developing microfluidic systems for nucleic acid and whole bacteria immunoassay tests, their practical application is limited by complex protocols, bulky peripherals, and slow operation. Here we present a microfluidic capillaric circuit (CC) optimized for rapid and automated detection of bacteria in urine. Molds for CCs were constructed using previously established design rules, then 3D-printed and replicated into poly(dimethylsiloxane). CCs autonomously and sequentially performed all liquid delivery steps required for the assay. For efficient bacteria capture, on-the-spot packing of antibody-functionalized microbeads was completed in <20 s followed by autonomous sequential delivery of 100 μL of bacteria sample, biotinylated detection antibodies, fluorescent streptavidin conjugate, and wash buffer for a total volume ≈115 μL. The assay was completed in <7 min. Fluorescence images of the microbead column revealed captured bacteria as bright spots that were easily counted manually or using an automated script for user-independent assay readout. The limit of detection of E. coli in synthetic urine was 1.2 × 102 colony-forming-units per mL (CFU/mL), which is well below the clinical diagnostic criterion (>105 CFU/mL) for UTI. The self-powered, peripheral-free CC presented here has potential for use in rapid point-of-care UTI screening.

Current practice of antibiotic utilization for renal colic in the emergency room.

ABSTRACTIntroduction Urinalysis (UA) in the emergency setting for patients with nephrolithiasis produces potentially confusing results leading to treatment of presumed urinary tract infections (UTIs). Our objective was to evaluate the use of antibiotics in patients with nephrolithiasis in a large network of emergency departments (EDs).Methods A retrospective analysis of all ED visits associated with an ICD-9 diagnosis of nephrolithiasis and a CT scan between 2010 and 2013 was performed. Urinalysis data, the use of IV and PO antibiotics during the ED visit and at discharge were assessed. The presence of fever, elevated serum WBCs, >5 WBCs per hpf, and/or dip positive nitrites were used as appropriate criteria for antibiotic use.Results Urinalysis data were available for 3,518 (70%) of 5,035 patients with an ED diagnosis of nephrolithiasis and CT imaging. Of these visits, 237 patients had positive nitrites (6.7%) and 864 had >5 WBCs per hpf (24.6%) with 158 (4.5%) having both findings for a total of 943 patients. Intravenous antibiotics were given to 244 patients (25.9%) and oral antibiotics were given to 629 patients (66.7 %) with positive UA findings. Of the 2,440 patients with a negative UA and no leukocytosis or fever, 86 patients (3.5%) received IV antibiotics and 533 patients (21.8%) received PO antibiotics upon discharge.Conclusions Proper treatment of nephrolithiasis in the ED includes the screening and diagnosis of concomitant UTIs. However, correct interpretation of UA studies is vital to the correct implementation of antibiotic therapy. This study suggests that 1/3 of patients were undertreated and 21.8% were over-treated.

The reliability and validity of using the urine dipstick test by patient self-assessment for urinary tract infection screening in spinal cord injury patients.

Aims:The aim of this is to evaluate the reliability of the urine dipstick test by patients’ self-assessment for urinary tract infection (UTI) screening and to determine the validity of urine dipstick test.Settings:Rehabilitation Department, Srinagarind Hospital, Thailand.Study Design:A diagnostic study.Subjects and Methods:This study compared the urine dipstick test (index test) with the National Institute on Disability and Rehabilitation Research (NIDRR) criteria (gold standard test) in spinal cord injury (SCI) patients. The urine dipstick test informed positive and negative results. Besides the NIDRR criteria classified as UTI and no UTI. The interrater reliability was measured in the sense of Kappa whereas the validity of urine dipstick test was reported in terms of sensitivity, specificity, positive likelihood ratio (LR) (+LR), negative LR (−LR), positive predictive value (PPV), and negative predictive value (NPV).Results:Out of the 56 participants, the kappa of urine dipstick test for leukocyte esterase, nitrite, and combined leukocyte esterase and nitrite were 0.09, 0.21, and 0.52, respectively. The nitrite urine dipstick test showed the highest sensitivity (90%). The combined leukocyte esterase and nitrite urine dipstick test gave the highest specificity (87%), PPV (60%), NPV (93%), and +LR (5.63).Conclusions:The interrater reliability of combined leukocyte esterase and nitrite urine dipstick test was moderate agreement. The combined leukocyte esterase and nitrite urine dipstick test showed high level of both sensitivity and specificity. The combined leukocyte esterase and nitrite urine dipstick test should be promoted for patients’ self-assessment for UTI screening in SCI patients.

Urinary tract infection among pregnant women at a secondary level hospital in Northern India.

Urinary tract infection (UTI) during pregnancy is frequently associated with complications. Currently, in India, there is no regular screening for UTI, and facility for diagnosis of UTI is not available at peripheral government health centers. To estimate the proportion of pregnant women with UTI among antenatal clinic attendees in rural Haryana. Eligible participants were pregnant women attending antenatal clinic of secondary care center of rural Haryana from March to May 2015. Consecutive sampling was done to select pregnant women. Interview schedule was administered to the selected women, and midstream urine sample was collected. Urine sample was plated on MacConkey agar, and colony count was done using standard methods. A total of 1253 pregnant women were included in the study. The proportion of women with symptoms of UTI on the basis of history was 33.3% (95% confidence interval [CI] - 30.7, 35.9), and UTI by colony count was 3.3% (95% CI - 2.4, 4.5). The presence of UTI was found to be significantly associated with the presence of any symptom of UTI on multivariate analysis (odds ratio [95% CI] - 7.35 [1.95, 27.77]). The burden of UTI among pregnant women attending antenatal clinic of a sub-district hospital was considerable, more so among the women that presented with symptoms suggestive of UTI. The study suggested that considering the burden of UTI and its complications, diagnosis of UTI at a resource-constrained setting like a secondary care hospital can be done after screening women for symptoms suggestive of UTI.

Urinary Tract Infections among HIV-Positive Pregnant Women in Mwanza City, Tanzania, Are High and Predicted by Low CD4+ Count.

Introduction. Urinary tract infection (UTI) among pregnant women can lead to adverse maternal and foetal outcomes. UTI has been widely studied in the general obstetric population in Tanzania; the present study evaluated the magnitude, antimicrobial resistance, and predictors of UTI among HIV-positive pregnant women. Methods. Between March and May 2016 midstream urine samples from 234 women attending prevention of mother to child transmission of HIV (PMTCT) clinics were analyzed using standard methods. Data was analyzed by STATA version 11.0. Results. The prevalence of UTI was 21.4%, 50/234 [95% CI: 16.1–26.6]. The asymptomatically significant bacteriuria was higher than symptomatically significant bacteriuria (16.6% versus 4.7%, p < 0.001). On multivariable logistic regression analysis, single marital status (OR: 2.6, 95% CI: 1.1–6.1, and p = 0.026), low CD4+ counts of <200/μL (OR: 2.9, 95% CI: 1.1–7.7, and p = 0.031), and having UTI symptoms (OR: 2.5, 95% CI: 1.1–6.0, and p = 0.03) were independent predictors of UTI. Escherichia coli predominated (57.7%) and exhibited a low prevalence of resistance to nitrofurantoin (16.7%), gentamicin (10.0%), and ceftriaxone (13.3%). Four (13.3%) of these were extended-spectrum beta-lactamase producers. Conclusions. A considerable proportion of HIV-positive pregnant women in Mwanza have significant bacteriuria which calls for the need to introduce routine UTI screening at PMTCT clinics to guide specific treatment and prevent associated complications.

Urinary tract infections in Romanian patients with diabetes: prevalence, etiology, and risk factors.

AimPatients with diabetes mellitus (DM) have an increased risk of infections, especially urinary tract infections (UTIs). The aim of this study was to assess the prevalence and etiology of UTIs and identify the risk factors for their development in patients with DM.Patients and methodsIn this retrospective, noninterventional study, the medical records of 2,465 adult patients with DM who were hospitalized in a Diabetes Clinic were reviewed. Data regarding the presence of UTI and possible associated risk factors were collected and their possible relation was analyzed. The study protocol and procedures were approved by the Ethics Committee of Timișoara Emergency Hospital. All data were collected and analyzed using SPSS v.17 statistical software.ResultsThe prevalence of UTIs in patients with DM was 12.0% (297 cases), being higher in females than in males and higher in patients with type 2 DM compared with patients with type 1 DM. In univariate logistic regression analysis, risk factors associated with UTIs were female gender, age, type 2 DM, longer duration of DM, and the presence of chronic kidney disease and coronary artery disease. Multivariate analysis identified age, duration of DM, and metabolic control (hemoglobin A1c levels) as independent risk factors for UTIs. The gram-negative bacilli from the Enterobacteriaceae family were predominant, with Escherichia coli being the most frequent of them (70.4%).ConclusionUTIs are a frequent condition associated with DM. It is necessary to improve the care and the screening of UTIs in patients with DM to prevent the occurrence of possible associated severe renal complications.

Screening Patients Undergoing Total Hip or Knee Arthroplasty with Perioperative Urinalysis and the Effect of a Practice Change on Antimicrobial Use.

OBJECTIVE To identify predictors of treatment for urinary tract infections (UTI) among patients undergoing total hip (THA) or knee (TKA) arthroplasties and to assess an intervention based on these predictors. DESIGN We conducted a retrospective cohort study of 200 consecutive patients undergoing THA/TKA between February 21, 2011, and June 30, 2011, to identify predictors of treatment for UTI and a prospective cohort study of 50 patients undergoing these procedures between May 21, 2012, and July 17, 2012, to assess the association of signs or symptoms and UTI treatment. We then conducted a before-and-after study to assess whether implementing an intervention affected the frequency of treatment for UTI before or after THA/TKA. SETTING The orthopedics department of a university health center. PATIENTS Patients undergoing THA or TKA. INTERVENTION Surgeons revised their UTI screening and treatment practices. RESULTS Positive leukocyte esterase (P5 (P=.01; P=.01) were associated with preoperative or postoperative UTI treatment. In the prospective study, 12 patients (24%) had signs and symptoms consistent with UTI. The number of patients treated for presumed UTI decreased 80.2% after the surgeons changed their practices, and surgical site infection (SSI) rates, including prosthetic joint infections (PJIs), did not increase. CONCLUSIONS Urine leukocyte esterase and white blood cell count were the strongest predictors of treatment for UTI before or after THA/TKA. The intervention was associated with a significant decrease in treatment for UTI, and SSI/PJI rates did not increase. Infect Control Hosp Epidemiol 2017;38:281-286.

Urinary tract infections in children and adolescents with acute psychosis

ObjectiveSchizophrenia is associated with increased infections. We previously found an association between urinary tract infection (UTI) and acute psychosis in adults. The aims of this study were to 1) evaluate the prevalence of UTI at the time of admission in children and adolescents with non-affective psychosis and psychotic depression versus those with non-psychotic major depressive disorder, and 2) compare demographic and clinical features between children and adolescents with acute psychosis with and without comorbid UTI. MethodWe performed a retrospective chart review of 227 subjects ages 10–18 who were hospitalized between 2005 and 2014 for an acute episode of DSM-IV non-affective psychosis (schizophrenia, schizoaffective disorder, psychosis NOS, or delusional disorder; n=80), major depressive disorder (MDD) with psychotic features (n=47); or MDD without psychotic features (n=100). ResultsThe prevalence of UTI was 20% in non-affective psychosis, 9% in MDD with psychotic features, and 13% in non-psychotic MDD. After controlling for potential confounders, UTI was 3.5 times more likely in subjects with non-affective psychosis than non-psychotic MDD (OR=3.5, 95% CI 1.3–9.2, p=0.01). Subjects with UTI had a higher prevalence of manic symptoms, but otherwise there were no associations between clinical characteristics and UTI in acute psychosis. ConclusionsWe found an association between UTIs and children and adolescents with acute non-affective psychosis. The results highlight the potential importance of screening for comorbid UTI in patients with acute psychosis.

Two-Step Process for ED UTI Screening in Febrile Young Children: Reducing Catheterization Rates: Lavelle JM, Blackstone, MM, Furari MK, et al. Pediatrics. 2016;138(1) doi: 10.1542/peds.2015-3023

Urinary tract infection (UTI) is an important source of febrile illness in young children; however due to the vague nature of signs and symptoms, particularly in a young nonverbal child, it is challenging to diagnose. Frequently children undergo urethral catheterization for both UTI screening and culture as opposed to the two-step screening process of first collecting urine by a noninvasive means to detect pyuria prior to proceeding with catheterization.

A diaper-embedded disposable nitrite sensor with integrated on-board urine-activated battery for UTI screening.

This paper reports a low-cost solution to the early detection of urinary nitrite, a common surrogate for urinary tract infection (UTI). We present a facile method to fabricate a disposable and flexible colorimetric [1] nitrite sensor and its urine-activated power source [2] on a hydrophobic (wax) paper through laser-assisted patterning and lamination. Such device, integrated with interface circuitry and a Bluetooth low energy (BLE) module can be embedded onto a diaper, and transmit semi-quantitative UTI monitoring information in a point-of-care and autonomous fashion. The proposed nitrite sensing platform achieves a sensitivity of 1.35 ms/(mg/L) and a detection limit of 4 mg/L.

Incidence of Nitrituria and Its Association With Metabolic Syndrome: Results From the Korean National Health and Nutrition Examination Survey V (2010-2012).

To investigate the incidence of nitrituria and the relationship between nitrituria and metabolic syndrome (MetS). Data from the Korean National Health and Nutrition Examination Survey V were used. A total of 19,083 participants were included. The chi-square test, the Mantel-Haenszel extension, logistic regression analysis, and multiple linear regression were used to analyze the data. A total of 2.0% of the participants had nitrituria. The incidence of nitrituria significantly increased with age (P trend<0.001). In addition, nitrituria in women began to significantly increase in the fifth decade, more than in men, and this difference was maintained in the 60s, 70s, and greater than 70s age groups (P<0.001). After adjusting for confounders, the odds ratio (OR) for nitrituria in the MetS group was significantly increased, as compared to the OR for nitrituria in the group without MetS (MetS: OR, 1.577; 95% confidence interval [CI], 1.134-2.192; P=0.007). The glycosylated hemoglobin of the nitrite positive group was significantly higher than the negative group (adjusted mean ±standard error: 6.108 ±0.081 vs. 5.883±0.065, P<0.001). An effective health policy for urinary tract infection (UTI) is needed for older age groups and women. Screening or management guidelines for UTI are needed in MetS patients.

Screening for Urinary Tract Infection Is Unnecessary in Prolonged Neonatal Jaundice

On the basis of scant medical evidence, urinary tract infection (UTI) is purported to be an etiology for prolonged jaundice in neonates. The U.K.'s National Institute for Health and Care Excellence recommends obtaining a urine culture in the diagnosis of neonates with jaundice lasting more than two …

Evaluation of the SediMax automated microscopy sediment analyzer and the Sysmex UF-1000i flow cytometer as screening tools to rule out negative urinary tract infections

Urinary tract infections (UTI) are highly prevalent in nosocomial and community settings, and their diagnosis is costly and time-consuming. Screening methods represent an important advance towards the final UTI diagnosis, diminishing inappropriate treatment or clinical complications. Automated analyzers have been developed and commercialized to screen and rule out negative urine samples. The aim of this study was to evaluate two of these automated analyzers (SediMax, an automatic sediment analyzer and UF-1000i a flow cytometer) to predict negative urine cultures. A total of 1934 urine samples were analyzed. A very strong correlation for white blood cells (WBC) (rs: 0.928) and a strong correlation for bacteria (BAC) (rs: 0.693) were obtained. We also calculated optimal cut-off points for both autoanalyzers: 18WBC/μL and 97BAC/μL for SediMax (sensitivity=96.25%, specificity=63.04%, negative predictive value=97.97%), and 40WBC/μL and 460BAC/μL for UF-1000i (sensitivity=98.13%, specificity=79.16%, negative predictive value=99.18%). The use of SediMax and UF-1000i resulted in a 46.33% and 57.19% reduction of all samples cultured, respectively. In conclusion, both analyzers are good UTI screening tools in our setting.

Urinary nitrite/nitrate ratio measured by isotope-dilution LC–MS/MS as a tool to screen for urinary tract infections

Urinary tract infections (UTIs) are the most common type of nosocomial infection. Traditionally, the presence of white blood cells and microorganisms in the urine provides objective evidence for UTI diagnosis. Here, we describe the use of liquid chromatography–tandem mass spectrometry (LC–MS/MS) to measure the nitrite and nitrate levels in urine and investigate the potential of this method for UTI diagnosis. LC–MS/MS analysis was performed in positive electrospray ionization mode. After adding 15N-labeled internal standards and derivatizing with 2,3-diaminonaphthalene (DAN), the urinary nitrite content was directly analyzed by LC–MS/MS, whereas the urinary nitrate was first reduced to nitrite before derivatization and LC–MS/MS analysis. The derivatization of nitrite and enzymatic reduction of nitrate were optimized. This method was then applied to 241 healthy subjects and 73 UTI patients. Optimization tests revealed that 1mL of crude urine required at least 6.25μmol of DAN to completely derivatize nitrite and 2.5U of nitrate reductase to completely reduce nitrate to nitrite. Urinary analysis showed that the urinary concentration of nitrite and the nitrite/nitrate ratio were higher in UTI patients than in healthy subjects. Compared with the dipstick-based urinary nitrite test and using LC–MS/MS to determine the nitrite concentration (sensitivity: 23–25%), the nitrite/nitrate ratio was significantly more sensitive (95%) and exhibited a satisfactory specificity (91%) in the screening of UTIs. Taken together, the nitrite/nitrate ratio, which reflects the reducing ability of pathogenic bacteria, could be a better method for the diagnosis of UTIs that is not subject to variations in urine specimen quality.

Value of urine sediment analyzer in the screening of urinary tract infection in cancer patients

To evaluate the value of urine sediment analyzer in the screening of clinically suspected urinary tract infection (UTI) in cancer patients. The results of bacterial count of 1 053 midstream urine samples by UF-1000i urine sediment analyzer (UF-1000i urine sediment analyzer, UF-1000i) were compared with the results of bacterial culture. Moreover, the results of distinguishing bacterial species by the bacterial scattergram were compared with the results of bacteria culture. At the same time, the sensitivity, specificity, positive predictive value and negative predictive value of UF-1000i analyzer for UTI screening were evaluated. Of all the 1 053 samples, the top three bacteria were E. coli, Enterococci and P. aeruginosa. The top three malignant tumors of UTI were bladder, lung cancer and cervical cancers. The positive rate of UF-1000i analyzer was 20% (211/1 053), and that of bacteria culture was 17.9% (188/1 053). There was statistically no significant difference in the positive rates between the two methods (χ(2)=1.636, P>0.05), and the two methods had a considerable consistency (Kappa=0.756). Compared with the clinical diagnosis, UTI screening by UF-1000i analyzer showed a sensitivity of 79.6% (160/201), specificity of 95.5% (814/852), positive predictive value of 80.8% (160/198) and negative predictive value of 95.2%(814/855). The distribution of cocci and bacilli acquired by the bacterial scattergram was basically in accordance with the results of bacterial culture. Bacterial count by UF-1000i analyzer plays an important role in early screening of UTI, and the bacterial scattergram may help to distinguish bacterial species, providing reference for the use of antibiotics in early medication.

Diagnostic performance of urine dipstick test for urinary tract infection screening in individuals with spinal cord injury

Objectives: To determine the diagnostic performance of urine dipstick test for urinary tract infection (UTI) screening in spinal cord injury (SCI) patients. Study Design: A cross-sectional diagnostic study. Setting: Srinagarind Hospital, Khon Kaen, Thailand. Participants: SCI patients with neurogenic bladder. Materials and Methods: This study was a cross-sectional diagnostic study that compared the urine dipstick test (index test) with the National Institute on Disability and Rehabilitation Research (NIDRR) criteria (gold standard test) in SCI patients. The urine dipstick test reported positive and negative results. Moreover, the NIDRR criteria classified participants as patients with UTI and patients with no UTI. The diagnostic performance of urine dipstick test for UTI screening was measured in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (+LR), and negative likelihood ratio (-LR) and was summarized in percentage with 95% confidence interval (CI). Results: Out of the 77 participants, most of participants were paraplegia (74%). The combined nitrite and leukocyte esterase urine dipstick test showed the highest sensitivity (93%), PPV (79%), NPV (85%), and +LR (2.39), respectively. The urine dipstick test of nitrite gave the highest specificity (69%). The most common uropathogen was Escherichia coli (33%). Conclusion: In SCI patients, the combined positive nitrite and leukocyte esterase urine dipstick test showed the highest sensitivity. The combined nitrite and leukocyte esterase urine dipstick test should be promoted as a screening test for UTI in SCI patients.

Screening and treatment of maternal genitourinary tract infections in early pregnancy to prevent preterm birth in rural Sylhet, Bangladesh: a cluster randomized trial.

BackgroundApproximately half of preterm births are attributable to maternal infections, which are commonly undetected and untreated in low-income settings. Our primary aim is to determine the impact of early pregnancy screening and treatment of maternal genitourinary tract infections on the incidence of preterm live birth in Sylhet, Bangladesh. We will also assess the effect on other adverse pregnancy outcomes, including preterm birth (stillbirth and live birth), late miscarriage, maternal morbidity, and early onset neonatal sepsis.Methods/DesignWe are conducting a cluster randomized controlled trial that will enroll 10,000 pregnant women in Sylhet district in rural northeastern Bangladesh. Twenty-four clusters, each with ~4000 population (120 pregnant women/year) and served by a community health worker (CHW), are randomized to: 1) the control arm, which provides routine antenatal and postnatal home-based care, or 2) the intervention arm, which includes routine antenatal and postnatal home-based care plus screening and treatment of pregnant women between 13 and 19 weeks of gestation for abnormal vaginal flora (AVF) and urinary tract infection (UTI). CHWs conduct monthly pregnancy surveillance, make 2 antenatal and 4 postnatal home visits for all enrolled pregnant women and newborns, and refer mothers or newborns with symptoms of serious illness to the government sub-district hospital. In the intervention clusters, CHWs perform home-based screening of AVF and UTI. Self-collected vaginal swabs are plated on slides, which are Gram stained and Nugent scored. Women with AVF (Nugent score ≥4) are treated with oral clindamycin, rescreened and retreated, if needed, after 3 weeks. Urine culture is performed and UTI treated with nitrofurantoin. Repeat urine culture is performed after 1 week for test of cure. Gestational age is determined by maternal report of last menstrual period at study enrollment using prospectively completed study calendars, and in a subset by early (<20 week) ultrasound. CHWs prospectively collect data on all pregnancy outcomes, maternal and neonatal morbidity and mortality.Implications/DiscussionFindings will enhance our understanding of the burden of AVF and UTI in rural Bangladesh, the impact of a maternal screening-treatment program for genitourinary tract infections on perinatal health, and help formulate public health recommendations for infection screening in pregnancy in low-resource settings.Trial registrationThe study was registered on ClinicalTrials.gov:NCT01572532 on December 15, 2011. The study was funded by NICHD: R01HD066156.