Clinical Trial: Treatment of Asymptomatic Bacteriuria in Pregnancy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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 Summary:

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.


Sponsor: Saint Joseph Mercy Health System

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Saint Joseph Mercy Health System

Dates:
Date Received: September 15, 2016
Date Started: September 2016
Date Completion: March 2019
Last Updated: September 20, 2016
Last Verified: September 2016