Skip to main content
OpenTrials
Completed

NCT Number: NCT03275623

Management of Sub-Clinical Bacteriuria in Pregnancy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystitis Cystitis;Puerperium Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Interstitial Pyelitis Pyelonephritis Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic

Drug

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

Other

Continued surveillance of urinary cultures

Primary outcomes

  1. Number of Participants Who Have Cystitis

    Time frame: about 10 months

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

  2. Number of Participants Who Have Pyelonephritis

    Time frame: about 10 months

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2017
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.