Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy of using peripheral blood for POC pregnancy testing in known pregnant participants.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POC serum pregnancy test arm | Enrolled participants will provide a peripheral serum specimen for POC pregnancy testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregnancy test | Diagnostic Test | POC pregnancy testing using peripheral serum |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant Female
Not provided
30 confirmed pregnant patients who present for their routine care visit to confirm efficacy of finger stick pregnancy test
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thanh T Nguyen, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | POC Serum Pregnancy Test Arm | Enrolled participants will provide a peripheral serum specimen for POC pregnancy testing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | POC Serum Pregnancy Test Arm | Enrolled participants will provide a peripheral serum specimen for POC pregnancy testing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Inclusion criteria 19 yrs or older |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All 30 peripheral serum specimens tested positive for pregnancy. | Posted | Count of Participants | Participants | One time test at time of enrollment |
|
|
30 Subject with No Adverse Events
No subject experienced an Adverse Event, as defined as Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. All subjects were monitored during sample collection.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | POC Serum Pregnancy Test Arm | Enrolled participant will provide a peripheral serum specimen for POC pregnancy testing. Adverse events were monitored while the participant remained in the clinic, which was approximately 30 minutes. |
Not provided
Not provided
Small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thanh Nguyen | University of Nebraska Medical Center | 402-559-7884 | thang.nguyen@unmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2025 | Mar 30, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2025 | Mar 30, 2026 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D011258 | Pregnancy Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
Not provided
Not provided
Not provided
Not provided
Not provided
specific patient age not collected, only confirmed age was 19 yrs or older
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | Exclusion criteria - Male gender | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
Not provided
Not provided
| D008919 | Investigative Techniques |