Cranberry for Prevention of Bacteriuria in Pregnancy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 4
- 主要终点
- Number of cases of asymptomatic bacteriuria
研究概览
简要总结
The purpose of this study is to determine the amount of cranberry juice that is most effective in preventing a condition in pregnant women that often leads to urinary tract infections (UTIs).
详细描述
Asymptomatic bacteriuria (ASB) infection, a condition in which a large number of bacteria are present in the urine, often precedes the development of symptomatic UTIs. UTIs are common among women and may create complications during pregnancy. By incorporating cranberry juice into their diets, pregnant women may be able to lower their risk for UTIs caused by ASB, and cranberry juice may also prevent preterm labor and birth. This study will determine the cranberry juice-containing regimen that will work best for preventing ASB in pregnant women.
For the duration of their pregnancy, participants in this study will be randomly assigned to one of three treatment arms: cranberry juice once a day, cranberry juice three times a day, or a placebo beverage three times a day. The level of bacteria in their urine will be measured at monthly study visits. Women who test positive for a UTI will receive oral antibiotic therapy. All women will be monitored throughout their pregnancies for UTIs and other related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
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
- •Intrauterine pregnancy
- •Mother and fetus in good health
- •Mother pregnant for 16 weeks or less
排除标准
- •Suspected nonviable or ectopic pregnancy
- •Mother plans to terminate pregnancy
- •Antimicrobial therapy, for reasons other than urinary tract infections, within 2 weeks prior to study start
- •Significant underlying medical complications that may interfere with the study
结局指标
主要结局
Number of cases of asymptomatic bacteriuria
次要结局
- Number of cases of symptomatic urinary tract infection
- Compliance with recommended therapy
- Number of preterm deliveries
