NCT01322958

Brief Summary

Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

6.3 years

First QC Date

April 20, 2010

Last Update Submit

January 14, 2014

Conditions

Ectopic Pregnancy

Keywords

bedside ultrasound

Outcome Measures

Primary Outcomes (1)

  • Clinical outcome of the pregnancy

    To measure the outcome of the study, we will base our results on Sensitivity and Specificity. Sensitivity which relates to the number of positive results defined as no intrauterine pregnancies, ectopic pregnancy compared to the Radiologic Gold standard ultrasound which provides us 100% sensitivity. The goal is to reach a sensitivity of (\>95%) by our ED physicians. Specificity which will be defined as the number of negative studies identified as intrauterine pregnancies compared to the results of the Gold standard radiology ultrasound and by telephone follow up.

    8 weeks

Study Arms (1)

At Risk of Ectopic Pregnancy

Women who present to the emergency department at UCSF who are at risk of ectopic pregnancy.

Device: Pelvic Ultrasound

Interventions

Pelvic UltrasoundDEVICE

Pelvic ultrasound performed by the emergency physician

Also known as: Pelvic Sonogram
At Risk of Ectopic Pregnancy

Eligibility Criteria

Age12 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women at risk of ectopic pregnancy in emergency department

You may qualify if:

  • pregnant females in 1st trimester
  • present to emergency department
  • complaint of abdominal/pelvic pain or vaginal bleeding

You may not qualify if:

  • previous ultrasound diagnostic of location of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • John C. Stein, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2010

First Posted

March 25, 2011

Study Start

February 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 16, 2014

Record last verified: 2014-01

Locations

US(1)