NCT01152528Unknown3 期
VA-SENSE - BACTERIAL VAGINOSIS ONCE A WEEK SCREENING AND TREATMENT TO REDUCE INFECTIVE COMPLICATIONS, ABORTION AND PRETERM DELIVERY IN PREGNANT WOMEN WITH PREVIOUS PRETERM DELIVERY.
Common Sense2 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2010年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Incidence of preterm birth, gestational week at delivery.
研究概览
简要总结
The purpose of this study is to determine whether screening of pregnant women with history of previous preterm delivery, once a week, for bacterial vaginosis using VA-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth. We will compare between the effectiveness of once a week screening and once during pregnancy screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant subjects, aged 18-50 years, pregnancy week 10 or less or 20 or less, with history of previous preterm delivery.
- •Subject is ready to sign an informed consent form.
排除标准
- •Subject with ruptured membranes.
- •Subject with signs and symptoms of bacterial vaginosis or Trichomoniasis infections.
- •Subject with blood in her vaginal secretions.
- •Subject is currently participating in another clinical study.
- •Subject is unable or unwilling to cooperate with study procedures.
结局指标
主要结局
Incidence of preterm birth, gestational week at delivery.
时间窗: 9 months
Each participant will use at least 8 VA-SENSE (maximum 20 TPLs), once a week for at least 8 weeks (maximum 20 weeks), or will be screened by VS-SENSE once during pregnancy.
次要结局
未报告次要终点
研究者
研究点 (2)
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