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Completed

NCT Number: NCT01322958

Sonographic Assessment and Visualization of Ectopics in Emergency Medicine

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

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Key information

Conditions

Ectopic Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

12 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

University of California

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic Ultrasound

Device

Pelvic ultrasound performed by the emergency physician

Other names: Pelvic Sonogram

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Acronym: SAVE'EM

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Mar 25, 2011
Registry last updated
Jan 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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