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

Not yet recruiting

• Conditions: Pregnancy Testing

• Registration Number: NCT06747598
• Lead Sponsor: University of Nebraska

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-27
• Study Start: 2025-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

• Does not meet inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
POC serum pregnancy testing	One time test at time of enrollment	A peripheral serum specimen will be used to test for pregnancy using a POC test. Outcome will be positive or negative

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States