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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01322958
First received: April 20, 2010
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Ectopic Pregnancy
Device: Pelvic Ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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

Blood


Enrollment: 600
Study Start Date: February 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

women at risk of ectopic pregnancy in emergency department

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322958

Locations
United States, California
University of California
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: John C. Stein, M.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01322958     History of Changes
Other Study ID Numbers: SAVE'EM
Study First Received: April 20, 2010
Last Updated: January 14, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
bedside ultrasound

Additional relevant MeSH terms:
Emergencies
Pregnancy, Ectopic
Cardiac Complexes, Premature
Disease Attributes
Pathologic Processes
Pregnancy Complications
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014