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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Other: Emergency Medicine Physician Ultrasound; Device: Ultrasound

• Registration Number: NCT02268877
• Lead Sponsor: Denver Health and Hospital Authority

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-20
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2017-05-01
• Results First Submitted QC: 2017-05-01
• Results First Posted: 2017-05-31
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emergency Medicine Physician Ultrasound	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	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.
Radiology Tech Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
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.