Skip to main content
OpenTrials
Completed

NCT Number: NCT02268877

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emergency Medicine Physician Ultrasound

Other

An ultrasound will be performed by an emergency medicine resident or attending physician

Ultrasound

Device

An ultrasound will be performed by a radiology department technician

Primary outcomes

  1. Time to Definitive Diagnosis

    Time frame: 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

  2. Emergency Department Length-of-Stay

    Time frame: 48 hours

    The time the patient is placed in room to the time that the patient is discharged/admitted.

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

  • United States Naval Medical Center, Portsmouth
  • United States Naval Medical Center, San Diego
  • University of Colorado, Denver

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2014
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.