Treatment of Asymptomatic Bacteriuria in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
3-day treatment
Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.
干预措施: Cephalexin (Drug)
3-day treatment
Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.
干预措施: Nitrofurantoin (Drug)
7-day treatment
Seven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.
干预措施: Cephalexin (Drug)
7-day treatment
Seven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy.
干预措施: Nitrofurantoin (Drug)
结局指标
主要结局
Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy.
时间窗: 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.
次要结局
- 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)
研究者
Pooja Green
Director of Obstetrical Research
Saint Joseph Mercy Health System