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Efficacy Evaluation of Using Finger Stick Peripheral Blood for Point of Care Pregnancy Testing (POCPREG)

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University of Nebraska

Status

Completed

Conditions

Pregnancy Testing

Treatments

Diagnostic Test: pregnancy test

Study type

Observational

Funder types

Other

Identifiers

NCT06747598
0755-24-EP

Details and patient eligibility

About

To evaluate the efficacy of using peripheral blood for POC pregnancy testing in known pregnant participants.

Full description

Point of care (POC) pregnancy tests are designed for use with a urine specimen. However, the timely collection of a urine specimen is solely dependent on the patient's need to urinate which can delay the initiation of subsequent care activities. Furthermore, when considering the limitations of urine POC testing in wilderness scenarios, collecting a urine specimen from an injured person may not be a viable option. The literature has demonstrated blood as a viable alternative specimen for use with POC pregnancy testing with a sensitivity of 95.8%. Based on a literature review, these studies used blood specimen that were pre-collected into a serum collection vial. The study postulates the use of peripheral blood via a finger stick has multiple benefits such as 1) eliminating the need to wait for urine, 2) expedite the serum collection process as compared to a venipucture, 3) allow for testing in non-traditional scenarios such as wilderness medicine or mass casualty/gathering scenarios, and 4) minimizing the amount of blood required as compared to a traditional 3-5 ml serum collection vial. Data from this pilot study will provide valuable insight on the potential use of this testing method to inform future studies and treatment protocols for the above mentioned scenarios.

Enrollment

30 patients

Sex

Female

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pregnant female, 19 years or older, being seen at the Nebraska Medicine OB/GYN clinic

Exclusion criteria

  • Does not meet inclusion criteria

Trial design

30 participants in 1 patient group

POC serum pregnancy test arm
Description:
Enrolled participants will provide a peripheral serum specimen for POC pregnancy testing
Treatment:
Diagnostic Test: pregnancy test

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Thanh T Nguyen, PhD

Data sourced from clinicaltrials.gov

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