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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Testing
• Intervention / Treatment: Diagnostic test: pregnancy test

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

30 confirmed pregnant patients who present for their routine care visit to confirm efficacy of finger stick pregnancy test

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Does not meet inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
POC serum pregnancy test arm; Enrolled participants will provide a peripheral serum specimen for POC pregnancy testing	Diagnostic test: pregnancy test; POC pregnancy testing using peripheral serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Positive POC Serum Pregnancy Test	A peripheral serum sample was collected through a finger stick point-of-care (POC) test to assess pregnancy in 30 women with previously confirmed pregnancies. The results were reported as either positive or negative.	One time test at time of enrollment

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Thanh T Nguyen, PhD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: POC pregnacy testing serum
• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Pregnancy Tests
• Other Study ID Numbers: 0755-24-EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No