Trial Outcomes & Findings for Management of Sub-Clinical Bacteriuria in Pregnancy (NCT NCT03275623)
NCT ID: NCT03275623
Last Updated: 2020-04-03
Results Overview
Cystitis is defined as a urine culture with \>100,000 CFU at any point during antenatal care.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
about 10 months
Results posted on
2020-04-03
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
25
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Sub-Clinical Bacteriuria in Pregnancy
Baseline characteristics by cohort
| Measure |
No Antibiotic Treatment
n=30 Participants
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
|
Antibiotic Treatment
n=30 Participants
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
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<20
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
20-34
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Customized
>=35
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: about 10 monthsPopulation: 2 participants in the "no antibiotic treatment" arm and 5 in the "antibiotic treatment" arm were not assessed for this outcome measure.
Cystitis is defined as a urine culture with \>100,000 CFU at any point during antenatal care.
Outcome measures
| Measure |
No Antibiotic Treatment
n=28 Participants
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
|
Antibiotic Treatment
n=25 Participants
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
|
|---|---|---|
|
Number of Participants Who Have Cystitis
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: about 10 monthsPopulation: 2 participants in the "no antibiotic treatment" arm and 5 in the "antibiotic treatment" arm were not assessed for this outcome measure.
Pyelonephritis is defined as a urine culture with \>100,000 CFU with fever at any point during antenatal care.
Outcome measures
| Measure |
No Antibiotic Treatment
n=28 Participants
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
|
Antibiotic Treatment
n=25 Participants
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
|
|---|---|---|
|
Number of Participants Who Have Pyelonephritis
|
3 Participants
|
4 Participants
|
Adverse Events
No Antibiotic Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Antibiotic Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jerrie S. Refuerzo, MD
The University of Texas Health Science Center at Houston
Phone: (713) 500-6416
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place