Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-31 @ 1:00 AM
Study NCT ID:
NCT02547857
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2015-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transvaginal Pelvic Ultrasound in the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'lastUpdateSubmitDate': '2016-12-23', 'studyFirstSubmitDate': '2015-06-15', 'studyFirstSubmitQcDate': '2015-09-10', 'lastUpdatePostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Method of finding ovaries', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'Will choose from:\n\n1. Adjacent to pelvic vessels\n2. Followed out from uterine cornu\n3. No particular method used'}, {'measure': 'Experience of sonographer', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'Choose from:\n\n1. G1\n2. G2\n3. G3-G5\n4. Physician Assistant (PA)\n5. Attending\n6. US tech'}, {'measure': 'Pelvic physical exam characteristics', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'Was there tenderness on the exam (right/left adnexa, suprapubic region, no tenderness)? Were any masses felt? (right/left adnexa, suprapubic, no mass)'}], 'primaryOutcomes': [{'measure': 'Change in diagnosis before/after pelvic US', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'The treating physician will be queried the likelihood of EMERGENT and NON-EMERGENT ovarian pathology before and after pelvic US using the following scale: Definite, Probable, Possible, Very Unlikely. The ED tests reviewed before each of these judgements will be noted. EMERGENT is defined as ovarian torsion or tubo-ovarian abscess (TOA). NON-EMERGENT is defined as all other causes, including ovarian cyst, ovarian mass, ovarian malignancy, adnexal mass). The clinician will also free text the most likely diagnosis. A change of two or more levels (eg definite to possible, definite to very unlikely, probable to very unlikely, or vice versa) will be assumed to be a significant change in diagnosis.'}, {'measure': 'Change in management plan before/after pelvic US', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'The treating physician will choose from the following regarding the management plan before/after the pelvic US: outpatient referral to OB/GYN, formal pelvic US after bedside US, consult GYN in the ED, urgent/emergent operative intervention, None of the above. Any difference in management before/after pelvic US will be considered a significant change in management.'}], 'secondaryOutcomes': [{'measure': 'Sonographic visualization of ovaries', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'yes/no'}, {'measure': 'Duration of pelvic US', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'Less than 5 minutes, 5-10 minutes, more than 10 minutes'}, {'measure': 'Ovary enlargement', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'Were the ovaries larger than 3.5 x 2 cm in any plane? yes/no answer'}, {'measure': 'Ovarian tenderness, sonographic', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'As a dichotomous yes/no. This will be correlated to final diagnosis. How many women with a non-tender ovary ended up with EMERGENT pathology? How many had NON-EMERGENT pathology?'}, {'measure': 'Ovarian blood flow', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'The physician will determine if the ovarian flow is normal in a dichotomous yes/no answer. (if performed)'}, {'measure': 'ED disposition after visit', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'This will measure if the patient is discharged from the ED or admitted to the hospital'}, {'measure': 'Final ED diagnosis', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'Two questions will be answered:\n\n1. Ovarian Pathology, Emergency (tubo-ovarian abscess, torsion)\n2. Ovarian Pathology, Non-Emergency (cyst, mass, malignancy)\n3. Non-ovarian problem\n\nQuestion 2:\n\nFinal ED diagnosis after all work-up: (select all that apply) checkbox\n\n1. ed\\_final\\_dx\\_2\\_\\_\\_1 ovarian cyst\n2. ed\\_final\\_dx\\_2\\_\\_\\_2 ovarian mass\n3. ed\\_final\\_dx\\_2\\_\\_\\_3 ovarian torsion\n4. ed\\_final\\_dx\\_2\\_\\_\\_4 tubo-ovarian abscess\n5. ed\\_final\\_dx\\_2\\_\\_\\_5 other ovarian pathology\n6. ed\\_final\\_dx\\_2\\_\\_\\_6 adnexal mass (non-ovarian)\n7. ed\\_final\\_dx\\_2\\_\\_\\_7 Pelvic Inflammatory Disease\n8. ed\\_final\\_dx\\_2\\_\\_\\_8 Abdominal pathology (appendicitis, diverticulitis, SBO, others)\n9. ed\\_final\\_dx\\_2\\_\\_\\_9 Non-specific abdominal pain\n10. ed\\_final\\_dx\\_2\\_\\_\\_10 None of the above and no ovarian pathology suspected'}, {'measure': '7-day follow-up', 'timeFrame': '7 days', 'description': 'Whether another facility was visited, whether a procedure occurred, and what else happened during this stay. Patients will be attempted to be contacted three times.'}, {'measure': 'Correlation between ED US and Formal US', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'If a formal US is obtained, the reading will be abstracted and compared to the ED US for the following: ovary visualization, ovary size, ovarian flow, final diagnosis, and any other abnormality in free text.'}, {'measure': 'Final impression for ED ultrasound with regards to ovaries', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'NORMAL or ABNORMAL. If abnormal, the abnormality will be described.'}, {'measure': 'Formal pelvic US', 'timeFrame': '8 hours (or less, this will measure what occurs during an ED stay)', 'description': 'Was this study obtained? dichotomous yes/no. And why was a formal pelvic US obtained? (abnormality of ovaries on bedside US; other abnormality on bedside US; unable to visualize ovaries on bedside US; good visualization of all structures and all structures normal, but post-test probability still high; Other (free text). )The exact reason will then be listed in free text.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pelvic ultrasound', 'Transvaginal ultrasound'], 'conditions': ['Abdominal Pain', 'Pelvic Pain']}, 'descriptionModule': {'briefSummary': 'Pelvic ultrasound is frequently performed in the ED in non-pregnant women to assess for ovarian pathology, though its use has not been described in the medical literature. This observational study aims to describe its use in clinical ED practice.', 'detailedDescription': "Pelvic ultrasound is frequently performed in the ED in non-pregnant women to assess for ovarian pathology. During the pelvic examination a transvaginal ultrasound probe is used to visualize ovarian size, determine echotexture, assess whether ovarian tenderness is present, and sometimes measure ovarian blood flow. Though pelvic ultrasound is used in the Hennepin County Medical Center ED routinely, there is a paucity of literature assessing it's utility.\n\nThis observational study will help determine the usefulness of this imaging modality, and how often it changes management in clinical practice.\n\nSpecifically, this study will attempt to determine how often transvaginal ultrasound identifies the structures of interest, and then will correlate these findings with the final ED diagnosis. If a formal ultrasound is obtained, the findings of the ED ultrasound will also be compared to the findings of the formal ultrasound.\n\nThe treating physicians will be queried the diagnosis and management plans before and after the pelvic US to ascertain changes in management."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult women for whom bedside transvaginal US is planned by their treating physician will be assessed for eligibility.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years old female\n* ED bedside transvaginal ultrasound to be performed in a non-pregnant woman with at least one ovary\n* Willing to discuss how they are doing at 7-10 days via phone\n* Valid phone number\n\nExclusion Criteria:\n\n* If a diagnosis of ovarian torsion, mass, TOA or other ovarian pathology is known before ED ultrasound\n* Previously enrolled in this study'}, 'identificationModule': {'nctId': 'NCT02547857', 'briefTitle': 'Transvaginal Pelvic Ultrasound in the ED', 'organization': {'class': 'OTHER', 'fullName': 'Hennepin Healthcare Research Institute'}, 'officialTitle': 'Transvaginal Pelvic Ultrasound in the ED', 'orgStudyIdInfo': {'id': 'HSR 14-3918'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'All women who undergo pelvic US in the ED, assuming they meet inclusion/exclusion criteria', 'interventionNames': ['Other: Pelvic US']}], 'interventions': [{'name': 'Pelvic US', 'type': 'OTHER', 'description': 'To be eligible for inclusion, a woman will have pelvic US completed as part of her ED stay. This is a non-interventional study.', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hennepin Healthcare Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Research Director', 'investigatorFullName': 'Brian Driver', 'investigatorAffiliation': 'Hennepin Healthcare Research Institute'}}}}