NCT06747598

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 26, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

December 3, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

December 18, 2024

Last Update Submit

November 25, 2025

Conditions

Pregnancy Testing

Keywords

POC pregnacy testing serum

Outcome Measures

Primary Outcomes (1)

  • POC serum pregnancy testing

    A peripheral serum specimen will be used to test for pregnancy using a POC test. Outcome will be 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 testDIAGNOSTIC_TEST

POC pregnancy testing using peripheral serum

POC serum pregnancy test arm

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Interventions

Pregnancy Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Obstetrical and GynecologicalInvestigative Techniques

Study Officials

  • Thanh T Nguyen, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

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

December 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)