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MIRA CONNECT Study
Sponsor: University of Colorado, Denver
Summary
The goal of this pilot study is to assess the accuracy and precision of an at-home quantitative urine beta hCG (b-hCG) test in the management of pregnancy of unknown location (PUL).
Official title: Assessing Accuracy and Precision of Home Quantitative Urine Beta hCG With Serum for Pregnancy of Unknown Location (CONNECT)
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2024-06-01
Completion Date
2027-09-30
Last Updated
2025-09-16
Healthy Volunteers
Yes
Conditions
Interventions
at-home quantitative urine b-hCG test
Cases will begin performing urine and serum hCG testing 24 hours after the initial hCG level. Urine hCG testing will be performed on the first morning urine at home and participants will limit water for at least 8 hours before testing. Serum hCG testing will occur at a UCHealth laboratory before 10 am and within 2 hours of the urine test to allow for the comparison of the values. Both urine and serum hCG testing will then occur daily x 7 days, or until a medical or surgical intervention is indicated. If serum testing is indicated on a weekend, patients will present to the UCH Infusion Center. Non-pregnant controls will test the first morning urine at home and undergo serum hCG testing in a UCHealth lab on the 4th and 6th day of the menstrual cycle. All urine hCG values will be recorded in the Mira home kit and evaluated in comparison to serum hCG levels.
Locations (1)
University of Colorado
Aurora, Colorado, United States