Treatment of Asymptomatic Bacteriuria in Pregnancy
April 16, 2018 updated by: Pooja Green, Saint Joseph Mercy Health System
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ypsilanti, Michigan, United States, 48197
- St. Joseph Mercy Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 3-day treatment
Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.
|
Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.
Other Names:
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.
|
Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.
Other Names:
Macrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy.
Time Frame: 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.
|
Within 21 days of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of development of cystitis during pregnancy.
Time Frame: Until 6 weeks postpartum
|
Comparison of percentage of women in each group who develop cystitis during pregnancy and the postpartum period.
|
Until 6 weeks postpartum
|
|
The occurence of preterm delivery
Time Frame: Assessed at the time of delivery
|
Comparison of the percentage of women in each group who deliver at <37 weeks gestation.
|
Assessed at the time of delivery
|
|
Comparison of development of pyelonephritis during pregnancy
Time Frame: Until 6 weeks postpartum
|
Comparison of percentage of women in each group who develop pyelonephritis during pregnancy and the postpartum period.
|
Until 6 weeks postpartum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Widmer M, Lopez I, Gulmezoglu AM, Mignini L, Roganti A. Duration of treatment for asymptomatic bacteriuria during pregnancy. Cochrane Database Syst Rev. 2015 Nov 11;2015(11):CD000491. doi: 10.1002/14651858.CD000491.pub3.
- 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. doi: 10.1016/s0891-5520(05)70375-5.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
September 15, 2016
First Submitted That Met QC Criteria
September 20, 2016
First Posted (Estimate)
September 22, 2016
Study Record Updates
Last Update Posted (Actual)
April 18, 2018
Last Update Submitted That Met QC Criteria
April 16, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSR-16-1661
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