Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2017-09-15
2019-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Antibiotic treatment
Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Antibiotic
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.
Standard Prenatal Care
Continued surveillance of urinary cultures
No antibiotic treatment
Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Standard Prenatal Care
Continued surveillance of urinary cultures
Interventions
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Antibiotic
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.
Standard Prenatal Care
Continued surveillance of urinary cultures
Eligibility Criteria
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Inclusion Criteria
* Urine culture of less than 100,000 CFU
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Akwugo Adanna Eziefule
Staff Physician
Principal Investigators
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Akwugo A Eziefule, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-17-0294
Identifier Type: -
Identifier Source: org_study_id
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