Abdominal PainNCT02547857
Transvaginal Pelvic Ultrasound in the ED
An observational study of Abdominal Pain and Pelvic Pain, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abdominal Pain, Pelvic Pain
- What is being tested?
- Pelvic US
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women for whom bedside transvaginal US is planned by their treating physician will be assessed for eligibility.
Who may be able to join
- 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
Who cannot join
- If a diagnosis of ovarian torsion, mass, TOA or other ovarian pathology is known before ED ultrasound
- Previously enrolled in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
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.
Read the 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.
- Conditions
- Abdominal Pain, Pelvic Pain
- Being tested
- Pelvic US
- Keywords
- Pelvic ultrasound, Transvaginal ultrasound
- Medical subject headings
- Abdominal Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic USOther
To be eligible for inclusion, a woman will have pelvic US completed as part of her ED stay. This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | All women who undergo pelvic US in the ED, assuming they meet inclusion/exclusion criteria Receives: Other: Pelvic US |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 hours (or less, this will measure what occurs during an ED stay)
Secondary outcomes (11)
Sonographic visualization of ovaries
yes/no
Measured: 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
Measured: 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
Measured: 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?
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 hours (or less, this will measure what occurs during an ED stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Driver, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547857
- Sponsor's protocol ID
- HSR 14-3918
- Status last verified
- Dec 2016
- First submitted
- 15 Jun 2015
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Pelvic Ultrasound in the ED
- ClinicalTrials.gov ID
- NCT02547857
- Acronym / sponsor ID
- HSR 14-3918
- Conditions
- Abdominal Pain, Pelvic Pain
- Keywords
- Pelvic ultrasound, Transvaginal ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2016 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Pelvic USAll women who undergo pelvic US in the ED, assuming they meet inclusion/exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women for whom bedside transvaginal US is planned by their treating physician will be assessed for eligibility.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- If a diagnosis of ovarian torsion, mass, TOA or other ovarian pathology is known before ED ultrasound
- Previously enrolled in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic USTo be eligible for inclusion, a woman will have pelvic US completed as part of her ED stay. This is a non-interventional study. | Other | Cohort 1 |
Primary outcome
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.
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.
11 secondary outcomes
Sonographic visualization of ovaries
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Duration of pelvic US
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Ovary enlargement
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Ovarian tenderness, sonographic
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Ovarian blood flow
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
ED disposition after visit
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Final ED diagnosis
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
7-day follow-up
Time frame: 7 days
Correlation between ED US and Formal US
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Final impression for ED ultrasound with regards to ovaries
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Formal pelvic US
Time frame: 8 hours (or less, this will measure what occurs during an ED stay)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Pain and Pelvic Pain, run by Hennepin Healthcare Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diagnosis before/after pelvic US (time frame: 8 hours (or less, this will measure what occurs during an ED stay)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.