Transvaginal Pelvic Ultrasound in the ED

NCT02547857 | Completed

• 1 other identifier: HSR 14-3918
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain; Pelvic Pain

Keywords

Pelvic ultrasound; Transvaginal ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Sonographic visualization of ovaries

  8 hours (or less, this will measure what occurs during an ED stay)

• Duration of pelvic US

  8 hours (or less, this will measure what occurs during an ED stay)

• Ovary enlargement

  8 hours (or less, this will measure what occurs during an ED stay)

• Ovarian tenderness, sonographic

  8 hours (or less, this will measure what occurs during an ED stay)

• Ovarian blood flow

  8 hours (or less, this will measure what occurs during an ED stay)

Other Outcomes (3)

• Method of finding ovaries

  8 hours (or less, this will measure what occurs during an ED stay)

• Experience of sonographer

  8 hours (or less, this will measure what occurs during an ED stay)

• Pelvic physical exam characteristics

  8 hours (or less, this will measure what occurs during an ED stay)

Study Arms (1)

Cohort 1

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

Other: Pelvic US

Interventions

Pelvic US 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.

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Abdominal Pain; Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Director

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: September 11, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2016
• Last Updated: December 28, 2016

Record last verified: 2016-12

Locations

US (1)