Phase 4
N=60
Management of Sub-Clinical Bacteriuria in Pregnancy
Cystitis · Cystitis;Puerperium · Pyelonephritis
Bottom Line
View on ClinicalTrials.gov: NCT03275623 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants Who Have Cystitis — 4; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Antibiotic (Drug); Standard Prenatal Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Have Cystitis |
4; 4 | — |
| PRIMARY Number of Participants Who Have Pyelonephritis |
3; 4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03275623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.