Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Clinical outcome of the pregnancy
研究概览
简要总结
Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy.
详细描述
Emergency Physicians who have undergone training according to the American College of Emergency Physicians Guidelines will be evaluated in the accuracy of performing pelvic ultrasounds among patients at risk for ectopic pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant females in 1st trimester
- •present to emergency department
- •complaint of abdominal/pelvic pain or vaginal bleeding
排除标准
- •previous ultrasound diagnostic of location of pregnancy
结局指标
主要结局
Clinical outcome of the pregnancy
时间窗: 8 weeks
To measure the outcome of the study, we will base our results on Sensitivity and Specificity. Sensitivity which relates to the number of positive results defined as no intrauterine pregnancies, ectopic pregnancy compared to the Radiologic Gold standard ultrasound which provides us 100% sensitivity. The goal is to reach a sensitivity of (\>95%) by our ED physicians. Specificity which will be defined as the number of negative studies identified as intrauterine pregnancies compared to the results of the Gold standard radiology ultrasound and by telephone follow up.
次要结局
未报告次要终点