- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03275623
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
Status
Completed
Conditions
Intervention / Treatment
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
-
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Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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-
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
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ACTIVE_COMPARATOR: No antibiotic treatment
Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
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Continued surveillance of urinary cultures
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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
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-17-0294
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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