Pregnancy
Conditions
Keywords
ultrasonography, emergency department
Brief summary
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
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.
Interventions
OTHEREmergency Medicine Physician Ultrasound
An ultrasound will be performed by an emergency medicine resident or attending physician
DEVICEUltrasound
An ultrasound will be performed by a radiology department technician
Sponsors
United States Naval Medical Center, Portsmouth
United States Naval Medical Center, San Diego
University of Colorado, Denver
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Definitive Diagnosis | 24 hours | 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 |
| Emergency Department Length-of-Stay | 48 hours | The time the patient is placed in room to the time that the patient is discharged/admitted. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Emergency Medicine Physician Ultrasound 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.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician | 118 |
| Radiology Tech Ultrasound 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.
Ultrasound: An ultrasound will be performed by a radiology department technician | 106 |
| Total | 224 |
Baseline characteristics
| Characteristic | Radiology Tech Ultrasound | Total | Emergency Medicine Physician Ultrasound |
|---|---|---|---|
| Age, Continuous | 26 years | 26 years | 26 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 106 participants | 224 participants | 118 participants |
| Sex: Female, Male Female | 106 Participants | 224 Participants | 118 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 106 |
| other Total, other adverse events | 4 / 118 | 2 / 106 |
| serious Total, serious adverse events | 2 / 118 | 2 / 106 |
Outcome results
Primary
Emergency Department Length-of-Stay
The time the patient is placed in room to the time that the patient is discharged/admitted.
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Emergency Medicine Physician Ultrasound | Emergency Department Length-of-Stay | 181 minutes |
| Radiology Tech Ultrasound | Emergency Department Length-of-Stay | 201 minutes |
Primary
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
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Emergency Medicine Physician Ultrasound | Time to Definitive Diagnosis | 87 minutes |
| Radiology Tech Ultrasound | Time to Definitive Diagnosis | 136 minutes |