MIRA CONNECT Study
Assessing Accuracy and Precision of Home Quantitative Urine Beta hCG With Serum for Pregnancy of Unknown Location (CONNECT)
University of Colorado, Denver
35 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria2
- Non-pregnant
- Diagnosed with PUL requiring ongoing surveillance of serum hCG levels
Exclusion Criteria12
- History of renal disease
- History of type I or type II diabetes
- Known malignancy of any diagnosis including hCG-secreting tumors (hepatobiliary tumors and neuroendocrine tumors) and ovarian germ cell tumors.
- Gestational Trophoblastic Disease
- Use of hormonal contraception within last 3 months
- Patients who work the night shift
- History of renal disease
- History of type I or type II diabetes
- Known malignancy of any diagnosis including hCG-secreting tumors (hepatobiliary tumors and neuroendocrine tumors) and ovarian germ cell tumors.
- Gestational Trophoblastic Disease
- Unstable patient, concern for ruptured ectopic pregnancy
- Initial serum hCG level > 100,000 mIU/ml
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Interventions
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)
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NCT06802263