Purpose

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

Condition

Eligibility

Eligible Ages
Over 19 Years
Eligible Sex
Female
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Thanh Nguyen
402-559-7884
thang.nguyen@unmc.edu

More Details

NCT ID
NCT06747598
Status
Recruiting
Sponsor
University of Nebraska

Study Contact

Thanh T Nguyen, PhD
402-559-7884
thang.nguyen@unmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.