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

NCT06747598 | Completed Results FDA Device

• 1 other identifier: 0755-24-EP
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Testing

Keywords

POC pregnacy testing serum

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

POC serum pregnancy test arm

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

Diagnostic Test: pregnancy test

Interventions

pregnancy test DIAGNOSTIC_TEST

POC pregnancy testing using peripheral serum

POC serum pregnancy test arm

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Pregnant Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Interventions

Pregnancy Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Investigative Techniques

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Thanh Nguyen
• Organization: University of Nebraska Medical Center

thang.nguyen@unmc.edu

402-559-7884

Study Officials

• Thanh T Nguyen, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: February 26, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)