Clinical trial NCT02547857: Transvaginal Pelvic Ultrasound in the ED
Official title: Transvaginal Pelvic Ultrasound in the ED
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Pain
Pelvic Pain
Keywords: Pelvic ultrasound
Transvaginal ultrasound
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult women for whom bedside transvaginal US is planned by their treating physician will be assessed for eligibility.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years old female
* ED bedside transvaginal ultrasound to be performed in a non-pregnant woman with at least one ovary
* Willing to discuss how they are doing at 7-10 days via phone
* Valid phone number

Exclusion Criteria:

* If a diagnosis of ovarian torsion, mass, TOA or other ovarian pathology is known before ED ultrasound
* Previously enrolled in this study

Primary outcomes:
measure: Change in diagnosis before/after pelvic US
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: Change in management plan before/after pelvic US
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
Secondary outcomes:
measure: Sonographic visualization of ovaries
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: Duration of pelvic US
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: Ovary enlargement
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: Ovarian tenderness, sonographic
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: Ovarian blood flow
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: ED disposition after visit
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: Final ED diagnosis
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: 7-day follow-up
timeFrame: 7 days
measure: Correlation between ED US and Formal US
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: Final impression for ED ultrasound with regards to ovaries
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: Formal pelvic US
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
Other outcomes:
measure: Method of finding ovaries
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: Experience of sonographer
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
measure: Pelvic physical exam characteristics
timeFrame: 8 hours (or less, this will measure what occurs during an ED stay)
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
References: