Cystitis, Cystitis;Puerperium, Pyelonephritis
Conditions
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.
Interventions
DRUGAntibiotic
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
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Have Cystitis | about 10 months | Cystitis is defined as a urine culture with \>100,000 CFU at any point during antenatal care. |
| Number of Participants Who Have Pyelonephritis | about 10 months | Pyelonephritis is defined as a urine culture with \>100,000 CFU with fever at any point during antenatal care. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Antibiotic Treatment Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Standard Prenatal Care: Continued surveillance of urinary cultures | 30 |
| Antibiotic Treatment Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Antibiotic: 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: Continued surveillance of urinary cultures | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | No Antibiotic Treatment | Antibiotic Treatment | Total |
|---|---|---|---|
| Age, Customized <20 | 6 Participants | 11 Participants | 17 Participants |
| Age, Customized 20-34 | 19 Participants | 12 Participants | 31 Participants |
| Age, Customized >=35 | 5 Participants | 7 Participants | 12 Participants |
| Race/Ethnicity, Customized Black | 17 Participants | 15 Participants | 32 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 9 Participants | 13 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment United States | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Number of Participants Who Have Cystitis
Cystitis is defined as a urine culture with \>100,000 CFU at any point during antenatal care.
Time frame: about 10 months
Population: 2 participants in the no antibiotic treatment arm and 5 in the antibiotic treatment arm were not assessed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Antibiotic Treatment | Number of Participants Who Have Cystitis | 4 Participants |
| Antibiotic Treatment | Number of Participants Who Have Cystitis | 4 Participants |
Primary
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.
Time frame: about 10 months
Population: 2 participants in the no antibiotic treatment arm and 5 in the antibiotic treatment arm were not assessed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Antibiotic Treatment | Number of Participants Who Have Pyelonephritis | 3 Participants |
| Antibiotic Treatment | Number of Participants Who Have Pyelonephritis | 4 Participants |