Bacteriuria (Asymptomatic) in Pregnancy
Conditions
Brief summary
This is a prospective randomized controlled day comparing the efficacy of three-day antimicrobial treatment of asymptomatic bacteriuria (ASB) in pregnancy to the standard seven-day treatment. Half the patients will receive 3-day treatment and the other half will receive 7 days of antibiotics.
Detailed description
The current standard of practice is to treat pregnant patients with ASB with a 7-day course of oral antimicrobial agents. If bacteriuria persists women are retreated with the same of different agent for a second course of 7 to 14 days and they may be subsequently placed on prophylaxis. In nonpregnant women, an uncomplicated lower urinary tract infection may be treated with a short course regimen from 1 to 3 days. This approach has similar rates of persistent bacteriuria or symptoms following treatment when compared to women treated with a more conventional approach. If the infection recurs or persists, the patient may then be treated with the more traditional 7 to 14 day course. The advantages of single-dose regimens are cost and patient compliance, but a major disadvantage is the failure to eradicate uropathogens from the vaginal reservoir, which results in more frequent early recurrences. The three-day regimen is advocated to maintain the advantages of lower costs and patient compliance but improving cure rates. Multiple studies have shown the advantage of even a short course of antibiotics as opposed to no treatment.
Interventions
DRUGCephalexin
Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.
DRUGNitrofurantoin
Macrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection.
Sponsors
Trinity Health Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women ≥ 18 years of age seeking prenatal care at the Academic Obstetrics and Gynecology Center at St. Joseph Mercy Hospital, Ann Arbor, Michigan * Randomization will occur if the patient every has a urine culture demonstrating ≥10,000 cfu/ml of a pathogenic urinary tract organism
Exclusion criteria
* Symptomatic bacteriuria (cystitis or pyelonephritis) at the time of urine collection * Previously treated bacteriuria in current pregnancy * Past medical history of known congenital or acquired urinary tract anomaly or abnormality (i.e. pelvic kidney, single kidney, renal transplant) * Any antibiotic use within the week prior to urine sampling * Urine culture revealing growth of the following organisms: Lactobacillus, coagulase-negative staphylococcus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy. | Within 21 days of treatment | Comparison of percentage of women in each group with successful treatment or asymptomatic bacteriuria with negative urine culture 2 weeks after randomized treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of development of cystitis during pregnancy. | Until 6 weeks postpartum | Comparison of percentage of women in each group who develop cystitis during pregnancy and the postpartum period. |
| The occurence of preterm delivery | Assessed at the time of delivery | Comparison of the percentage of women in each group who deliver at \<37 weeks gestation. |
| Comparison of development of pyelonephritis during pregnancy | Until 6 weeks postpartum | Comparison of percentage of women in each group who develop pyelonephritis during pregnancy and the postpartum period. |
Countries
United States
Outcome results
None listed