Management of Sub-Clinical Bacteriuria in Pregnancy

Phase 4

Completed

• Conditions: Cystitis;Puerperium; Pyelonephritis; Cystitis
• Interventions: Drug: Antibiotic; Other: Standard Prenatal Care

• Registration Number: NCT03275623
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-07
• Study Start: 2017-09-15
• Primary Completion: 2019-03-18
• Study Completion: 2019-03-18
• Status Verified: 2020-03
• Results First Submitted: 2020-03-19
• Results First Submitted QC: 2020-03-19
• Last Update Submitted: 2020-03-19
• Results First Posted: 2020-04-03
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic treatment	Standard Prenatal Care	Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Antibiotic treatment	Antibiotic	Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
No antibiotic treatment	Standard Prenatal Care	Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Have Pyelonephritis	about 10 months	Pyelonephritis is defined as a urine culture with \>100,000 CFU with fever at any point during antenatal care.
Number of Participants Who Have Cystitis	about 10 months	Cystitis is defined as a urine culture with \>100,000 CFU at any point during antenatal care.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States