Sofia hCG FIA Field Study

Completed

Conditions studied: Pregnancy, Early Detection

In brief

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.

Key facts

Study ID

NCT01803113

Run by

Quidel Corporation

People needed

975

Starts

2013-01-01

Expected to finish

2013-03-01

Last updated by the study team

2013-03-13

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female subjects of childbearing age, who are being screened for pregnancy and who have signed the informed consent

You may not qualify if…

• 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.

Where it is running

• Jose Castaneda, MD — Boynton Beach, Florida, United States
• NECCR of Massachusetts, LLC — Fall River, Massachusetts, United States
• New England Center for Clinical Research Fall River,LLC (NECCR) — Fall River, Massachusetts, United States
• Partners In Obstetrics and Gynecology, Inc. — Pawtucket, Rhode Island, United States
• Planned Parenthood Gulf Coast — Houston, Texas, United States

Full record on ClinicalTrials.gov

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