Sonographic Assessment and Visualization of Ectopics in Emergency Medicine

Ectopic Pregnancy Clinical Trial

— SAVE'EM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322958
• Other study ID #: SAVE'EM
• Status: Completed
• Phase: N/A
• First received: April 20, 2010
• Last updated: January 14, 2014
• Start date: February 2007
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 55 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Device:
• Pelvic Ultrasound
Pelvic ultrasound performed by the emergency physician

Locations

Country	Name	City	State
United States	University of California	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No