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Completed

NCT Number: NCT02547857

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in diagnosis before/after pelvic US

    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.

  2. Change in management plan before/after pelvic US

    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.

Secondary outcomes

  1. Sonographic visualization of ovaries

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

    yes/no

  2. Duration of pelvic US

    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

  3. Ovary enlargement

    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

  4. Ovarian tenderness, sonographic

    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?

  5. Ovarian blood flow

    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)

  6. ED disposition after visit

    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

  7. Final ED diagnosis

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

    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. 7-day follow-up

    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.

  9. Correlation between ED US and Formal US

    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.

  10. Final impression for ED ultrasound with regards to ovaries

    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.

  11. Formal pelvic US

    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.

Other outcomes

  1. Method of finding ovaries

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

    Will choose from:

    • Adjacent to pelvic vessels
    • Followed out from uterine cornu
    • No particular method used
  2. Experience of sonographer

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

    Choose from:

    • G1
    • G2
    • G3-G5
    • Physician Assistant (PA)
    • Attending
    • US tech
  3. Pelvic physical exam characteristics

    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)

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
First posted
Sep 11, 2015
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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