Transvaginal Pelvic Ultrasound in the ED

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Pelvic Pain
• Intervention / Treatment: Other: Pelvic US

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.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Adult women for whom bedside transvaginal US is planned by their treating physician will be assessed for eligibility.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; All women who undergo pelvic US in the ED, assuming they meet inclusion/exclusion criteria	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in diagnosis before/after pelvic US	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.	8 hours (or less, this will measure what occurs during an ED stay)
Change in management plan before/after pelvic US	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.	8 hours (or less, this will measure what occurs during an ED stay)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sonographic visualization of ovaries	yes/no	8 hours (or less, this will measure what occurs during an ED stay)
Duration of pelvic US	Less than 5 minutes, 5-10 minutes, more than 10 minutes	8 hours (or less, this will measure what occurs during an ED stay)
Ovary enlargement	Were the ovaries larger than 3.5 x 2 cm in any plane? yes/no answer	8 hours (or less, this will measure what occurs during an ED stay)
Ovarian tenderness, sonographic	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?	8 hours (or less, this will measure what occurs during an ED stay)
Ovarian blood flow	The physician will determine if the ovarian flow is normal in a dichotomous yes/no answer. (if performed)	8 hours (or less, this will measure what occurs during an ED stay)
ED disposition after visit	This will measure if the patient is discharged from the ED or admitted to the hospital	8 hours (or less, this will measure what occurs during an ED stay)
Final ED diagnosis	Two questions will be answered: Ovarian Pathology, Emergency (tubo-ovarian abscess, torsion); Ovarian Pathology, Non-Emergency (cyst, mass, malignancy); Non-ovarian problem Question 2: Final ED diagnosis after all work-up: (select all that apply) checkbox; ed_final_dx_2___1 ovarian cyst; ed_final_dx_2___2 ovarian mass; ed_final_dx_2___3 ovarian torsion; ed_final_dx_2___4 tubo-ovarian abscess; ed_final_dx_2___5 other ovarian pathology; ed_final_dx_2___6 adnexal mass (non-ovarian); ed_final_dx_2___7 Pelvic Inflammatory Disease; ed_final_dx_2___8 Abdominal pathology (appendicitis, diverticulitis, SBO, others); ed_final_dx_2___9 Non-specific abdominal pain; ed_final_dx_2___10 None of the above and no ovarian pathology suspected	8 hours (or less, this will measure what occurs during an ED stay)
7-day follow-up	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.	7 days
Correlation between ED US and Formal US	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.	8 hours (or less, this will measure what occurs during an ED stay)
Final impression for ED ultrasound with regards to ovaries	NORMAL or ABNORMAL. If abnormal, the abnormality will be described.	8 hours (or less, this will measure what occurs during an ED stay)
Formal pelvic US	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.	8 hours (or less, this will measure what occurs during an ED stay)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Method of finding ovaries	Will choose from: Adjacent to pelvic vessels; Followed out from uterine cornu; No particular method used	8 hours (or less, this will measure what occurs during an ED stay)
Experience of sonographer	Choose from: G1; G2; G3-G5; Physician Assistant (PA); Attending; US tech	8 hours (or less, this will measure what occurs during an ED stay)
Pelvic physical exam characteristics	Was there tenderness on the exam (right/left adnexa, suprapubic region, no tenderness)? Were any masses felt? (right/left adnexa, suprapubic, no mass)	8 hours (or less, this will measure what occurs during an ED stay)

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Estimate): December 28, 2016
• Last Update Submitted That Met QC Criteria: December 23, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Transvaginal ultrasound; Pelvic ultrasound
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Pelvic Pain
• Other Study ID Numbers: HSR 14-3918