Determining Beta-hCG Levels in Patients Through Alternative Sample Types

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-11

Study Completion Date

2023-06-23

Brief Summary

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This study is to determine if there is any quantifiable correlation between serum beta hCG and dried blood spot (DBS) beta hCG levels. This data will be used to develop a less invasive collection method to determine quantitative hCG levels.

Detailed Description

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A cohort of 40 individuals at various stages of pregnancy or medical abortion will be recruited for the study. Each participant will provide biospecimens that include the following: serum, saliva, urine, and dried blood spot (DBS). These samples will be collected and stored at the clinic under appropriate storage conditions until they can be shipped, under dry ice, to the testing lab. Once samples arrive at the lab, serum samples will be thawed and prepared to run on an ECL analyzer to determine reference beta hCG values in mIU/mL for each participant.

Samples will be run as they are received by the lab. The initial 10-12 samples will be used to evaluate study feasiblility and determine if there is one sample type that performs better than the others. The other matched sample types will be processed and run on the ECL analyzer. The values for beta hCG mIU/mL of the other sample types will then be compared to the matched serum to determine if there are any consistent correlations.

In the first 10-12 samples, if one sample type is shown to perform better than the others, the study will shift focus towards prioritizing the analysis of that particular sample type in regards to correlation with serum. If more than one sample type is shown to perform well, then those sample types will be equally prioritized. If no sample type shows any correlation, the study will end.

Conditions

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Pregnancy Related Abortion

Keywords

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Simple HealthKit

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Participants (qualified)

This arm consists of participants who are able to collect all sample types No intervention is administered

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Are at least 18 years old
* Have not taken antibiotics in the last 21 days
* Are here for services related to a current or recent pregnancy
* Agree to provide all required samples
* Have not previously participated in this study

Exclusion Criteria

* Are under18 years old
* Have taken antibiotics in the last 21 days
* Are not here for services related to a current or recent pregnancy
* Disagree or unable to provide all required samples
* Have previously participated in this study

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Berry, MD

Role: PRINCIPAL_INVESTIGATOR

Planned Parenthood Great Northwest, Hawai'I, Alaska, Indiana, Kentucky

Locations

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Planned Parenthood of the Great Northwest, Hawai'i, Alaska, Indiana and Kentucky

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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SHK_007

Identifier Type: -

Identifier Source: org_study_id