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Clinical Trials/NCT01322958
NCT01322958
Completed
Not Applicable

Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)

University of California, San Francisco1 site in 1 country600 target enrollmentFebruary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ectopic Pregnancy
Sponsor
University of California, San Francisco
Enrollment
600
Locations
1
Primary Endpoint
Clinical outcome of the pregnancy
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 2007
End Date
June 2013
Last Updated
12 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • pregnant females in 1st trimester
  • present to emergency department
  • complaint of abdominal/pelvic pain or vaginal bleeding

Exclusion Criteria

  • previous ultrasound diagnostic of location of pregnancy

Outcomes

Primary Outcomes

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.

Study Sites (1)

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