Treatment of Asymptomatic Bacteriuria in Pregnancy
- Conditions
- Bacteriuria (Asymptomatic) in Pregnancy
- Interventions
- Registration Number
- NCT02911662
- Lead Sponsor
- Saint Joseph Mercy Health System
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 13
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3-day treatment Nitrofurantoin Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy. 7-day treatment Cephalexin Seven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy. 3-day treatment Cephalexin Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy. 7-day treatment Nitrofurantoin Seven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
St. Joseph Mercy Hospital
🇺🇸Ypsilanti, Michigan, United States