Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
NCT Number: NCT02547857
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.
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Notify Me18 year and older
Female
Observational
Minneapolis, Minnesota, 55415, United States
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.
This observational study will help determine the usefulness of this imaging modality, and how often it changes management in clinical practice.
Specifically, 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.
The treating physicians will be queried the diagnosis and management plans before and after the pelvic US to ascertain changes in management.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To be eligible for inclusion, a woman will have pelvic US completed as part of her ED stay. This is a non-interventional study.
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
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.
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
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.
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
yes/no
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Less than 5 minutes, 5-10 minutes, more than 10 minutes
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Were the ovaries larger than 3.5 x 2 cm in any plane? yes/no answer
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
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?
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
The physician will determine if the ovarian flow is normal in a dichotomous yes/no answer. (if performed)
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
This will measure if the patient is discharged from the ED or admitted to the hospital
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Two questions will be answered:
Question 2:
Final ED diagnosis after all work-up: (select all that apply) checkbox
Time frame: 7 days
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.
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
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.
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
NORMAL or ABNORMAL. If abnormal, the abnormality will be described.
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
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.
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Will choose from:
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Choose from:
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Was there tenderness on the exam (right/left adnexa, suprapubic region, no tenderness)? Were any masses felt? (right/left adnexa, suprapubic, no mass)
Hennepin Healthcare Research Institute
Other
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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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