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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06747598
Acronym
POCPREG
Enrollment
30
Registered
2024-12-24
Start date
2025-02-26
Completion date
2025-08-01
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Testing

Keywords

POC pregnacy testing serum

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.

Interventions

DIAGNOSTIC_TESTpregnancy test

POC pregnancy testing using peripheral serum

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Positive POC Serum Pregnancy TestOne time test at time of enrollmentA 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORThanh T Nguyen, PhD

University of Nebraska

Baseline characteristics

Characteristic
Age, Customized
Age
30 Participants
Sex/Gender, Customized
Female
30 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 30
other
Total, other adverse events
0 / 30
serious
Total, serious adverse events
0 / 30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026