Ectopic PregnancySAVE'EMNCT01322958
Sonographic Assessment and Visualization of Ectopics in Emergency Medicine
An observational study of Ectopic Pregnancy, run by University of California, San Francisco at 1 site in United States.
Trial summary
Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy. Read more about this study
- Who is it for?
- Ages 12 to 55 years, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Pelvic Ultrasound
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: women at risk of ectopic pregnancy in emergency department
Who may be able to join
- pregnant females in 1st trimester
- present to emergency department
- complaint of abdominal/pelvic pain or vaginal bleeding
Who cannot join
- previous ultrasound diagnostic of location of pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94143
About this study
Official title: Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)
Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy.
Read the detailed description
Emergency Physicians who have undergone training according to the American College of Emergency Physicians Guidelines will be evaluated in the accuracy of performing pelvic ultrasounds among patients at risk for ectopic pregnancy.
- Conditions
- Ectopic Pregnancy
- Being tested
- Pelvic Ultrasound
- Keywords
- bedside ultrasound
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic UltrasoundDevice
Also called Pelvic Sonogram
Pelvic ultrasound performed by the emergency physician
| Study group | Role | What they receive |
|---|---|---|
| At Risk of Ectopic Pregnancy | Women who present to the emergency department at UCSF who are at risk of ectopic pregnancy. Receives: Device: Pelvic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startFeb 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- John C. Stein, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322958
- Sponsor's protocol ID
- SAVE'EM
- Acronym
- SAVE'EM
- Status last verified
- Jan 2014
- First submitted
- 20 Apr 2010
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)
- ClinicalTrials.gov ID
- NCT01322958
- Acronym / sponsor ID
- SAVE'EM / SAVE'EM
- Conditions
- Ectopic Pregnancy
- Keywords
- bedside ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Feb 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy.
Detailed description
Emergency Physicians who have undergone training according to the American College of Emergency Physicians Guidelines will be evaluated in the accuracy of performing pelvic ultrasounds among patients at risk for ectopic pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At Risk of Ectopic Pregnancy | – | Device: Pelvic UltrasoundWomen who present to the emergency department at UCSF who are at risk of ectopic pregnancy. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- women at risk of ectopic pregnancy in emergency department
Key inclusion criteria (3 listed)
- pregnant females in 1st trimester
- present to emergency department
- complaint of abdominal/pelvic pain or vaginal bleeding
Key exclusion criteria (1 listed)
- previous ultrasound diagnostic of location of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic UltrasoundAlso: Pelvic SonogramPelvic ultrasound performed by the emergency physician | Device | At Risk of Ectopic Pregnancy |
Primary outcome
Clinical outcome of the pregnancy
Time frame: 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
Related trials for Ectopic Pregnancy
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
RecruitingPhase 2
Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS
Mild Autonomous Cortisol Secretion (MACS), Autonomous Cortisol Secretion (ACS)
Active, not recruitingPhase 2
Metyrapone for Mild Autonomous Cortisol Secretion (MACS)
Autonomous Cortisol Secretion, Mild Autonomous Cortisol Secretion (MACS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C. Stein, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ectopic Pregnancy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome of the pregnancy (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014.