Pregnancy RelatedNCT06178224
Determining Beta-hCG Levels in Patients Through Alternative Sample Types
An observational study of Pregnancy Related and Abortion, run by Simple HealthKit at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Abortion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2022to 23 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood of the Great Northwest, Hawai'i, Alaska, Indiana and Kentucky
Tacoma, Washington, 98405
About this study
Official title: Determination of Quantitative Beta-hCG Levels in Patients Through Alternative and Less Invasive Sample Types
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.
Read the 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.
- Conditions
- Pregnancy Related, Abortion
- Keywords
- Simple HealthKit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants (qualified) | This arm consists of participants who are able to collect all sample types No intervention is administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of matched serum and DBS samples for detection of beta hCG levels using an ECL analyzer.
It was determine that serum and DBS samples show a consistent correlation. DBS beta hCG levels can be converted to reflect those of serum beta hCG. By utilization of a dilution factor, DBS beta hCG levels matched that of serum beta hCG levels with an average accuracy of 94.8%.
Serum samples were run on an analyzer to obtain reference values in mIU/mL. Dried blood spot (DBS) samples, that were matched for both time of collection and patient, were extracted with an elution buffer coupled with agitation. This eluate was run on the same analyzer as the serum samples and the resulting beta hCG levels in mIU/mL were corrected with a dilution factor and compared to the serum reference values.
Measured: 2-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start11 Oct 2022
- Primary completion19 Apr 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simple HealthKit
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Planned Parenthood Federation of America, Planned Parenthood Great Northwest, Hawai'I, Alaska, Indiana, Kentucky
- Responsible party
- Sponsor
- Investigators
- Erin Berry, MD, Principal investigator, Planned Parenthood Great Northwest, Hawai'I, Alaska, Indiana, Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178224
- Sponsor's protocol ID
- SHK_007
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Quantitative Beta-hCG Levels in Patients Through Alternative and Less Invasive Sample Types
- ClinicalTrials.gov ID
- NCT06178224
- Acronym / sponsor ID
- SHK_007
- Conditions
- Pregnancy Related, Abortion
- Keywords
- Simple HealthKit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Simple HealthKitIndustry (pharma, biotech, devices)
- Collaborators
- Planned Parenthood Federation of America, Planned Parenthood Great Northwest, Hawai'I, Alaska, Indiana, Kentucky
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants (qualified) | – | –This arm consists of participants who are able to collect all sample types No intervention is administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of matched serum and DBS samples for detection of beta hCG levels using an ECL analyzer.
Time frame: 2-24 hours
It was determine that serum and DBS samples show a consistent correlation. DBS beta hCG levels can be converted to reflect those of serum beta hCG. By utilization of a dilution factor, DBS beta hCG levels matched that of serum beta hCG levels with an average accuracy of 94.8%. Serum samples were run on an analyzer to obtain reference values in mIU/mL. Dried blood spot (DBS) samples, that were matched for both time of collection and patient, were extracted with an elution buffer coupled with agitation. This eluate was run on the same analyzer as the serum samples and the resulting beta hCG levels in mIU/mL were corrected with a dilution factor and compared to the serum reference values.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Berry, MD principal investigator
Planned Parenthood Great Northwest, Hawai'I, Alaska, Indiana, Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Abortion, run by Simple HealthKit at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of matched serum and DBS samples for detection of beta hCG levels using an ECL analyzer. (time frame: 2-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.