NCT02911662

Treatment of Asymptomatic Bacteriuria in Pregnancy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Trinity Health Michigan · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bacteriuria (Asymptomatic) in Pregnancy

Interventions

Type	Name	Description
DRUG	Cephalexin	Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.
DRUG	Nitrofurantoin	Macrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-09-22
• Last updated: 2018-04-18

Locations

1 site across 1 country: United States