Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01322958|
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : January 16, 2014
|Condition or disease||Intervention/treatment|
|Ectopic Pregnancy||Device: Pelvic Ultrasound|
|Study Type :||Observational|
|Actual Enrollment :||600 participants|
|Official Title:||Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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
- Clinical outcome of the pregnancy [ Time Frame: 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|