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

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 Overview

• Status: Completed
• Conditions: Ectopic Pregnancy
• Intervention / Treatment: Device: Pelvic Ultrasound

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.

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women at risk of ectopic pregnancy in emergency department

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: Pelvic Sonogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome of the pregnancy	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.	8 weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: John C. Stein, M.D., University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 20, 2010
• First Submitted That Met QC Criteria: March 23, 2011
• First Posted (Estimate): March 25, 2011

Study Record Updates

• Last Update Posted (Estimate): January 16, 2014
• Last Update Submitted That Met QC Criteria: January 14, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: bedside ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Emergencies; Pregnancy, Ectopic; Cardiac Complexes, Premature
• Other Study ID Numbers: SAVE'EM