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Clinical Trials/NCT02268877
NCT02268877
Completed
Not Applicable

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

Denver Health and Hospital Authority0 sites224 target enrollmentMarch 2013
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Denver Health and Hospital Authority
Enrollment
224
Primary Endpoint
Time to Definitive Diagnosis
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
March 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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.

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