Management of Sub-Clinical Bacteriuria in Pregnancy

Study Overview
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Brief Summary
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The purpose of the study is to determine if treatment of pregnant women with urine cultures with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease adverse pregnancy outcomes.

Official Title
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Management of Sub-Clinical Bacteriuria in Pregnancy: A Feasibility Trial

Conditions
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Cystitis, Cystitis;Puerperium, Pyelonephritis

Intervention / Treatment
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* Drug: Antibiotic
* Other: Standard Prenatal Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women who seek prenatal care within the University of Texas Health System with UT Physicians. Urine culture of less than 100,000 CFU Exclusion Criteria: Less than 18 years of age Risk factors to complicated UTI (including but not limited to: diverticula, urolithiasis, renal cysts, indwelling catheter, intermittent catheterization, stent placements, nephrostomy tubes, neurogenic bladder, cystocele, vesicoureteral reflux, ileal conduit) Use of immunosuppressant drugs Abnormalities of the urinary tract (including but not limited to: known ureteric or urethral strictures, tumors of the urinary tract, pelvicalyceal obstruction, congenital anomalies, history of urological procedures) History of renal disease including renal failure and transplants Urine culture > 100,000 CFU of any organism

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antibiotic treatment<br>Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism. | Drug: Antibiotic<br>* Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.<br>Other: Standard Prenatal Care<br>* Continued surveillance of urinary cultures<br>|
| Active Comparator: No antibiotic treatment<br>Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism. | Other: Standard Prenatal Care<br>* Continued surveillance of urinary cultures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Have Cystitis | Cystitis is defined as a urine culture with >100,000 CFU at any point during antenatal care. | about 10 months | 
| Number of Participants Who Have Pyelonephritis | Pyelonephritis is defined as a urine culture with >100,000 CFU with fever at any point during antenatal care. | about 10 months |