Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)
Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)|
- Clinical outcome of the pregnancy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||February 2007|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
At Risk of Ectopic Pregnancy
Women who present to the emergency department at UCSF who are at risk of ectopic pregnancy.
Device: Pelvic Ultrasound
Pelvic ultrasound performed by the emergency physician
Other Name: Pelvic Sonogram
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322958
|United States, California|
|University of California|
|San Francisco, California, United States, 94143|
|Principal Investigator:||John C. Stein, M.D.||University of California, San Francisco|