Comparison of Beta-hCG Levels When Using Venous Puncture... | NCT07493720

Studies
Comparison of Beta-hCG Levels When Using Venous Puncture Blood and Peripheral Finger Stick Blood

NCT07493720

Sponsor

University of Nebraska

Status

Not yet recruiting

Last Update Posted

Mar 25, 2026Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Pregnancy

Interventions

Beta-hCG

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Mar 19, 2026

First Submission Date that Met QC Criteria

Mar 19, 2026

First Posted Date

Mar 25, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2026

Last Update Posted Date

Mar 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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. This data will help the investigator compare trending levels of beta-hCG levels in pregnant patients between venous blood vs peripheral blood which may help determine levels at which the peripheral blood may no longer be detectable on a POC pregnancy test.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1		19 years of age or older, positive pregnancy status	Diagnostic Test: Beta-hCG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Beta-hCG	Diagnostic Test	Enrolled participants will provide 2 serum specimens (venipuncture and peripheral finger stick) for beta-hCG testing	Cohort 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Beta-hCG value	Venipuncture and peripheral finger stick serum will be tested for beta-hCG levels.	Once on date of enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria: No meeting the inclusion criteria

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Biological female

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thanh Nguyen, PhD	Contact	14025597884		thang.nguyen@unmc.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nebraska Medical Center		Omaha	Nebraska	68198-1150	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21875776	Result	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.

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D003944	Diagnostic Techniques, Obstetrical and Gynecological