Treatment of Asymptomatic Bacteriuria in Pregnancy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 3-day treatment Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy. |
Drug: Cephalexin
Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.
Other Names:
Drug: Nitrofurantoin
Macrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection.
Other Names:
|
| Active Comparator: 7-day treatment Seven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy. |
Drug: Cephalexin
Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.
Other Names:
Drug: Nitrofurantoin
Macrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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)
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Any antibiotic use within the week prior to urine sampling
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Urine culture revealing growth of the following organisms: Lactobacillus, coagulase-negative staphylococcus
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Joseph Mercy Hospital | Ypsilanti | Michigan | United States | 48197 |
Sponsors and Collaborators
- Saint Joseph Mercy Health System
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Patterson TF, Andriole VT. Detection, significance, and therapy of bacteriuria in pregnancy. Update in the managed health care era. Infect Dis Clin North Am. 1997 Sep;11(3):593-608. Review.
- Romero R, Oyarzun E, Mazor M, Sirtori M, Hobbins JC, Bracken M. Meta-analysis of the relationship between asymptomatic bacteriuria and preterm delivery/low birth weight. Obstet Gynecol. 1989 Apr;73(4):576-82.
- Widmer M, Lopez I, Gülmezoglu AM, Mignini L, Roganti A. Duration of treatment for asymptomatic bacteriuria during pregnancy. Cochrane Database Syst Rev. 2015 Nov 11;(11):CD000491. doi: 10.1002/14651858.CD000491.pub3. Review.
- HSR-16-1661