Management of Sub-Clinical Bacteriuria in Pregnancy

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Cystitis; Pyelonephritis; Cystitis;Puerperium

Treatments: Other: Standard Prenatal Care; Drug: Antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03275623

HSC-MS-17-0294

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Antibiotic treatment

Active Comparator group

Description:

Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.

Treatment:

Other: Standard Prenatal Care

Drug: Antibiotic

No antibiotic treatment

Active Comparator group

Description:

Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.

Treatment:

Other: Standard Prenatal Care