MIRA CONNECT Study

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06802263
Status
Recruiting
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Conditions

  • Pregnancy of Unknown Location (PUL)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • at-home quantitative urine b-hCG test — DIAGNOSTIC_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.

Study Details

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).

Key Dates

Start date
Jun 1, 2024
Status verified
Sep 2025
Primary completion
Mar 2, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Sham Comparator: CNTRL: Non-pregnant control patients
    Non-pregnant patients will use the pregnancy test device
  • Active Comparator: PUL: Pregnancy unknown location diagnosis
    Pregnant patients with unknown location diagnosis will use the pregnancy test device

Primary Outcome Measure

Urine b-hCG [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045
Cara Clure, MD
[email protected]
720-445-6396
Jocelyn Phipers, NP
[email protected]
303-724-7807
Cara Clure, MD (PRINCIPAL_INVESTIGATOR)

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University of Colorado· Aurora, CO