Management of Sub-Clinical Bacteriuria in Pregnancy

The University of Texas Health Science Center, Houston60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystitis Cystitis;Puerperium Pyelonephritis

Interventions

AntibioticDRUG

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 CareOTHER

Continued surveillance of urinary cultures

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Participants Who Have Cystitis

Cystitis is defined as a urine culture with \>100,000 CFU at any point during antenatal care.

Time frame: 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.

Time frame: about 10 months

Data from ClinicalTrials.gov

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