Back to resultsManagement of Sub-Clinical Bacteriuria in Pregnancy
Primary Purpose
Cystitis, Cystitis;Puerperium, Pyelonephritis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Antibiotic
Standard Prenatal Care
Sponsored by
About this trial
This is an interventional treatment trial for Cystitis
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Antibiotic treatment
No antibiotic treatment
Arm Description
Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Outcomes
Primary Outcome Measures
Number of Participants Who Have Cystitis
Cystitis is defined as a urine culture with >100,000 CFU at any point during antenatal care.
Number of Participants Who Have Pyelonephritis
Pyelonephritis is defined as a urine culture with >100,000 CFU with fever at any point during antenatal care.
Secondary Outcome Measures
Full Information
NCT ID
NCT03275623
First Posted
September 5, 2017
Last Updated
March 19, 2020
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03275623
Brief Title
Management of Sub-Clinical Bacteriuria in Pregnancy
Official Title
Management of Sub-Clinical Bacteriuria in Pregnancy: A Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
March 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Cystitis;Puerperium, Pyelonephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antibiotic treatment
Arm Type
Active Comparator
Arm Description
Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Arm Title
No antibiotic treatment
Arm Type
Active Comparator
Arm Description
Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Intervention Type
Drug
Intervention Name(s)
Antibiotic
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Prenatal Care
Intervention Description
Continued surveillance of urinary cultures
Primary Outcome Measure Information:
Title
Number of Participants Who Have Cystitis
Description
Cystitis is defined as a urine culture with >100,000 CFU at any point during antenatal care.
Time Frame
about 10 months
Title
Number of Participants Who Have Pyelonephritis
Description
Pyelonephritis is defined as a urine culture with >100,000 CFU with fever at any point during antenatal care.
Time Frame
about 10 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akwugo A Eziefule, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Management of Sub-Clinical Bacteriuria in Pregnancy
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