A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography

Study Overview
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Brief Summary
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The goal of this project is to compare the efficiency of pelvic ultrasounds performed by emergency medicine residents and attending physicians to the efficiency of pelvic ultrasounds performed by the department of radiology.

Detailed Description
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This study is a randomized, prospective interventional study of pregnant patients presenting to the emergency department with complaints of pelvic pain and/or vaginal bleeding. This study will be conducted at 4 sites across the United States. Patients who are eligible and consent to participate will be randomized to one of two conditions; 1) a pelvic ultrasound that is performed by a certified emergency department attending or physician, or 2) a pelvic ultrasound that is performed by a certified radiology technician (standard-of-care). The time to diagnosis and emergency department length of stay between the two groups will be compared.

Official Title
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A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography

Conditions
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Pregnancy

Intervention / Treatment
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* Other: Emergency Medicine Physician Ultrasound
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a positive serum or urine beta-human chorionic gonadotropin (hCG) estimated gestational age (EGA) of less than 20 weeks complaint of pelvic pain and/or vaginal bleeding Exclusion Criteria: prior known documentation of an intrauterine pregnancy estimated gestational age (EGA) of greater than 20 weeks peritoneal findings on physical examination unstable vital signs as deemed appropriate by the attending physician prisoners open cervix upon physical examination

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emergency Medicine Physician Ultrasound<br>Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound. | Other: Emergency Medicine Physician Ultrasound<br>* An ultrasound will be performed by an emergency medicine resident or attending physician<br>Device: Ultrasound<br>* An ultrasound will be performed by a radiology department technician<br>|
| Active Comparator: Radiology Tech Ultrasound<br>Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care. | Device: Ultrasound<br>* An ultrasound will be performed by a radiology department technician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Definitive Diagnosis | The time the patient is placed in room to the time that results of the ultrasound (and/or consultative impression made by radiology or obstetrics and gynecology) are documented in patient chart | 24 hours | 
| Emergency Department Length-of-Stay | The time the patient is placed in room to the time that the patient is discharged/admitted. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasonography, emergency department