Treatment of Asymptomatic Bacteriuria in Pregnancy

Sponsors

Lead Sponsor: Saint Joseph Mercy Health System

Source Saint Joseph Mercy Health System
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.

Overall Status Terminated
Start Date September 2016
Completion Date January 2018
Primary Completion Date January 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy. Within 21 days of treatment
Secondary Outcome
Measure Time Frame
Comparison of development of cystitis during pregnancy. Until 6 weeks postpartum
The occurence of preterm delivery Assessed at the time of delivery
Comparison of development of pyelonephritis during pregnancy Until 6 weeks postpartum
Enrollment 13
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cephalexin

Description: Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.

Other Name: Keflex

Intervention Type: Drug

Intervention Name: Nitrofurantoin

Description: Macrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection.

Other Name: Macrobid

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: St. Joseph Mercy Hospital
Location Countries

United States

Verification Date

April 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Saint Joseph Mercy Health System

Investigator Full Name: Pooja Green

Investigator Title: Director of Obstetrical Research

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 3-day treatment

Type: Experimental

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

Label: 7-day treatment

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov