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

Denver Health and Hospital Authority

Status: Completed

Conditions: Pregnancy

Treatments: Device: Ultrasound; Other: Emergency Medicine Physician Ultrasound

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02268877

11-1444

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Emergency Medicine Physician Ultrasound

Experimental group

Description:

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.

Treatment:

Other: Emergency Medicine Physician Ultrasound

Device: Ultrasound

Radiology Tech Ultrasound

Active Comparator group

Description:

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.

Treatment:

Device: Ultrasound