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Treatment of Asymptomatic Bacteriuria in Pregnancy

Primary Purpose

Bacteriuria (Asymptomatic) in Pregnancy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cephalexin
Nitrofurantoin
Sponsored by
Saint Joseph Mercy Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacteriuria (Asymptomatic) in Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • St. Joseph Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3-day treatment

7-day treatment

Arm Description

Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.

Seven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.

Outcomes

Primary Outcome Measures

Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy.
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.
Comparison of percentage of women in each group who develop cystitis during pregnancy and the postpartum period.
The occurence of preterm delivery
Comparison of the percentage of women in each group who deliver at <37 weeks gestation.
Comparison of development of pyelonephritis during pregnancy
Comparison of percentage of women in each group who develop pyelonephritis during pregnancy and the postpartum period.

Full Information

First Posted
September 15, 2016
Last Updated
April 16, 2018
Sponsor
Saint Joseph Mercy Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02911662
Brief Title
Treatment of Asymptomatic Bacteriuria in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Inability to enroll patients at anticipated rate.
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Joseph Mercy Health System

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteriuria (Asymptomatic) in Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3-day treatment
Arm Type
Experimental
Arm Description
Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.
Arm Title
7-day treatment
Arm Type
Active Comparator
Arm Description
Seven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.
Intervention Type
Drug
Intervention Name(s)
Cephalexin
Other Intervention Name(s)
Keflex
Intervention Description
Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin
Other Intervention Name(s)
Macrobid
Intervention Description
Macrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection.
Primary Outcome Measure Information:
Title
Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy.
Description
Comparison of percentage of women in each group with successful treatment or asymptomatic bacteriuria with negative urine culture 2 weeks after randomized treatment.
Time Frame
Within 21 days of treatment
Secondary Outcome Measure Information:
Title
Comparison of development of cystitis during pregnancy.
Description
Comparison of percentage of women in each group who develop cystitis during pregnancy and the postpartum period.
Time Frame
Until 6 weeks postpartum
Title
The occurence of preterm delivery
Description
Comparison of the percentage of women in each group who deliver at <37 weeks gestation.
Time Frame
Assessed at the time of delivery
Title
Comparison of development of pyelonephritis during pregnancy
Description
Comparison of percentage of women in each group who develop pyelonephritis during pregnancy and the postpartum period.
Time Frame
Until 6 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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) Any antibiotic use within the week prior to urine sampling Urine culture revealing growth of the following organisms: Lactobacillus, coagulase-negative staphylococcus
Facility Information:
Facility Name
St. Joseph Mercy Hospital
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26560337
Citation
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.
Results Reference
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PubMed Identifier
9378925
Citation
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.
Results Reference
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PubMed Identifier
2927852
Citation
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.
Results Reference
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Treatment of Asymptomatic Bacteriuria in Pregnancy

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