NCT07493720

Brief Summary

The objective of his study is to quantitatively evaluate a patient's pregnancy status using their beta-hCG levels when using venipuncture blood vs peripheral blood.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

March 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 19, 2026

Last Update Submit

March 19, 2026

Conditions

Pregnancy

Keywords

pregnancy

Outcome Measures

Primary Outcomes (1)

  • Beta-hCG value

    Venipuncture and peripheral finger stick serum will be tested for beta-hCG levels.

    Once on date of enrollment

Study Arms (1)

Cohort 1

19 years of age or older, positive pregnancy status

Diagnostic Test: Beta-hCG

Interventions

Beta-hCGDIAGNOSTIC_TEST

Enrolled participants will provide 2 serum specimens (venipuncture and peripheral finger stick) for beta-hCG testing

Cohort 1

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiological female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

19 years of age, positive pregnant status recorded in EMR, presenting to Nebraska Medicine OB/GYN clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-1150, United States

Location

Related Publications (1)

  • Fromm C, Likourezos A, Haines L, Khan AN, Williams J, Berezow J. Substituting whole blood for urine in a bedside pregnancy test. J Emerg Med. 2012 Sep;43(3):478-82. doi: 10.1016/j.jemermed.2011.05.028. Epub 2011 Aug 27.

    PMID: 21875776RESULT

MeSH Terms

Interventions

Pregnancy Tests

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Thanh Nguyen, PhD

CONTACT

14025597884thang.nguyen@unmc.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)