Determining Beta-hCG Levels in Patients Through Alternative Sample Types

NCT06178224 | Completed

• 1 other identifier: SHK_007
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Abortion

Keywords

Simple HealthKit

Outcome Measures

Primary Outcomes (1)

• 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.

  2-24 hours

Study Arms (1)

Participants (qualified)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Simple HealthKit: lead
• Planned Parenthood Federation of America: collaborator
• Planned Parenthood Great Northwest, Hawai'I, Alaska, Indiana, Kentucky: collaborator

Study Sites (1)

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

Tacoma, Washington, 98405, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples collected from each user are: Urine Saliva Serum dried blood spot (DBS)

Study Officials

• Erin Berry, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 20, 2023
• Study Start: October 11, 2022
• Primary Completion: April 19, 2023
• Study Completion: June 23, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

US (1)