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Transvaginal Pelvic Ultrasound in the ED

NCT ID: NCT02547857

Last Updated: 2016-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Abdominal Pain Pelvic Pain

Keywords

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Pelvic ultrasound Transvaginal ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

All women who undergo pelvic US in the ED, assuming they meet inclusion/exclusion criteria

Pelvic US

Intervention Type OTHER

To be eligible for inclusion, a woman will have pelvic US completed as part of her ED stay. This is a non-interventional study.

Interventions

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Pelvic US

To be eligible for inclusion, a woman will have pelvic US completed as part of her ED stay. This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hennepin Healthcare Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Brian Driver

Associate Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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HSR 14-3918

Identifier Type: -

Identifier Source: org_study_id