Clinical trial NCT06178224: Determining Beta-hCG Levels in Patients Through Alternative Sample Types
Official title: Determination of Quantitative Beta-hCG Levels in Patients Through Alternative and Less Invasive Sample Types
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Abortion
Keywords: Simple HealthKit
Lead sponsor: Simple HealthKit
Sponsor class: INDUSTRY
Collaborators: name: Planned Parenthood Federation of America
name: Planned Parenthood Great Northwest, Hawai'I, Alaska, Indiana, Kentucky
First posted: 2023-12-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consists of individuals who are of 18 years or older that are currently pregnant or undergoing medical abortion. All of the participants will come from affiliated Planned Parenthood clinics.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of matched serum and DBS samples for detection of beta hCG levels using an ECL analyzer.
timeFrame: 2-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Planned Parenthood of the Great Northwest, Hawai'i, Alaska, Indiana and Kentucky
state: Washington
Study officials:
affiliation: Planned Parenthood Great Northwest, Hawai'I, Alaska, Indiana, Kentucky
name: Erin Berry, MD
role: PRINCIPAL_INVESTIGATOR
References: