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

NCT ID: NCT06747598

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-26
• Study Completion Date: 2025-08-01

Brief Summary

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

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.

Conditions

Pregnancy Testing

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

POC serum pregnancy test arm

Enrolled participants will provide a peripheral serum specimen for POC pregnancy testing

pregnancy test

Intervention Type: DIAGNOSTIC_TEST

POC pregnancy testing using peripheral serum

Interventions

pregnancy test

POC pregnancy testing using peripheral serum

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thanh T Nguyen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

0755-24-EP

Identifier Type: -

Identifier Source: org_study_id