Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-21 @ 2:44 PM
Study NCT ID:
NCT01322958
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2010-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonographic Assessment and Visualization of Ectopics in Emergency Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-14', 'studyFirstSubmitDate': '2010-04-20', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcome of the pregnancy', 'timeFrame': '8 weeks', 'description': 'To measure the outcome of the study, we will base our results on Sensitivity and Specificity.\n\nSensitivity 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.\n\nSpecificity 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bedside ultrasound'], 'conditions': ['Ectopic Pregnancy']}, 'descriptionModule': {'briefSummary': 'Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women at risk of ectopic pregnancy in emergency department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant females in 1st trimester\n* present to emergency department\n* complaint of abdominal/pelvic pain or vaginal bleeding\n\nExclusion Criteria:\n\n* previous ultrasound diagnostic of location of pregnancy'}, 'identificationModule': {'nctId': 'NCT01322958', 'acronym': "SAVE'EM", 'briefTitle': 'Sonographic Assessment and Visualization of Ectopics in Emergency Medicine', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': "Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)", 'orgStudyIdInfo': {'id': "SAVE'EM"}}, 'armsInterventionsModule': {'armGroups': [{'label': 'At Risk of Ectopic Pregnancy', 'description': 'Women who present to the emergency department at UCSF who are at risk of ectopic pregnancy.', 'interventionNames': ['Device: Pelvic Ultrasound']}], 'interventions': [{'name': 'Pelvic Ultrasound', 'type': 'DEVICE', 'otherNames': ['Pelvic Sonogram'], 'description': 'Pelvic ultrasound performed by the emergency physician', 'armGroupLabels': ['At Risk of Ectopic Pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'John C. Stein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}