Management of Sub-Clinical Bacteriuria in Pregnancy

March 19, 2020 updated by: Akwugo Adanna Eziefule, The University of Texas Health Science Center, Houston

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

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 Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Antibiotic treatment
Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
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.
Continued surveillance of urinary cultures
ACTIVE_COMPARATOR: No antibiotic treatment
Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Continued surveillance of urinary cultures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
about 10 months
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.
about 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Akwugo A Eziefule, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2017

Primary Completion (ACTUAL)

March 18, 2019

Study Completion (ACTUAL)

March 18, 2019

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (ACTUAL)

September 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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