Pregnancy, Early DetectionNCT01803113
Sofia hCG FIA Field Study
An observational study of Pregnancy, Early Detection, run by Quidel Corporation at 5 sites in United States.
Trial summary
The objective of this field study is to demonstrate the clinical performance of the Sofia hCG FIA Test, using urine specimens from females of childbearing age. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy, Early Detection
- What is being tested?
- Sofia hCG FIA
- Type of treatment
- Medical device
- How many people
- 975 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2013to Mar 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any female of childbearing potential being screened for pregnancy
Who may be able to join
- Female subjects of childbearing age, who are being screened for pregnancy and who have signed the informed consent
Who cannot join
- Subject is post-menopausal.
- Subject within the past six weeks has experienced any of the following: delivered a newborn; had an abortion or a natural termination (miscarriage); or, received hCG supplements.
- Subject has had a hysterectomy.
- Unable to understand and consent to participation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Jose Castaneda, MD
Boynton Beach, Florida, 33435-7959
NECCR of Massachusetts, LLC
Fall River, Massachusetts, 02720
New England Center for Clinical Research Fall River,LLC (NECCR)
Fall River, Massachusetts, 02720
Planned Parenthood Gulf Coast
Houston, Texas, 77023
Partners In Obstetrics and Gynecology, Inc.
Pawtucket, Rhode Island, 02860
About this study
The objective of this field study is to demonstrate the clinical performance of the Sofia hCG FIA Test, using urine specimens from females of childbearing age.
Read the detailed description
Subjects presenting for pregnancy testing will provide urine specimens that will be tested with the Sofia hCG FIA test and the comparator pregnancy test that will detect levels of hCG of 20mIU as positive for pregnancy.
- Conditions
- Pregnancy, Early Detection
- Being tested
- Sofia hCG FIA
- Keywords
- Pregnancy, hCG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofia hCG FIADevice
Qualitative detection via immunofluorescence technology of increased level of hCG present in urine.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of presence of hCG in urine
Clinical performance will be based on comparison of Sofia hCG FIA test results to those obtained from an FDA-cleared hCG test.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, Early DetectionStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 975 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quidel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803113
- Sponsor's protocol ID
- CS-0144-01
- Status last verified
- Mar 2013
- First submitted
- 21 Feb 2013
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sofia hCG FIA Field Study
- ClinicalTrials.gov ID
- NCT01803113
- Acronym / sponsor ID
- CS-0144-01
- Conditions
- Pregnancy, Early Detection
- Keywords
- Pregnancy, hCG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 975 participants (actual)
- Lead sponsor
- Quidel CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Mar 2013 (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.
The objective of this field study is to demonstrate the clinical performance of the Sofia hCG FIA Test, using urine specimens from females of childbearing age.
Detailed description
Subjects presenting for pregnancy testing will provide urine specimens that will be tested with the Sofia hCG FIA test and the comparator pregnancy test that will detect levels of hCG of 20mIU as positive for pregnancy.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any female of childbearing potential being screened for pregnancy
Key inclusion criteria (1 listed)
- Female subjects of childbearing age, who are being screened for pregnancy and who have signed the informed consent
Key exclusion criteria (4 listed)
- Subject is post-menopausal.
- Subject within the past six weeks has experienced any of the following: delivered a newborn; had an abortion or a natural termination (miscarriage); or, received hCG supplements.
- Subject has had a hysterectomy.
- Unable to understand and consent to participation.
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 |
|---|---|---|
| Sofia hCG FIAQualitative detection via immunofluorescence technology of increased level of hCG present in urine. | Device | – |
Primary outcome
Determination of presence of hCG in urine
Time frame: 1 day
Clinical performance will be based on comparison of Sofia hCG FIA test results to those obtained from an FDA-cleared hCG test.
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 13 Mar 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Early Detection, run by Quidel Corporation at 5 sites 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 1 inclusion and 4 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 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Determination of presence of hCG in urine (time frame: 1 day). 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 13 Mar 2013.