MIRA CONNECT Study: At-Home Urine Test for Pregnancy of Unknown Location
This study is looking at how well an at-home urine test, called the Mira quantitative urine b-hCG test, can measure hormone levels in women with a Pregnancy of Unknown Location (PUL). A PUL means that a pregnancy has been confirmed, but its location (inside or outside the uterus) can't be seen on an ultrasound. The study aims to see if this at-home test can accurately track these hormone levels, potentially reducing the need for frequent clinic visits. You could be eligible if you are a woman between 18 and 40 years old and have been diagnosed with a PUL requiring ongoing monitoring of your hormone levels. The study will compare the at-home test results with standard blood tests over 7 days. The current recruitment status is unclear, and the study plans to enroll 35 participants.
- Study design
- This is an interventional study, not specifying a phase, and plans to enroll 35 participants (30 with PUL and 5 non-pregnant controls).
- What's involved
- If you have a PUL, you will perform urine and blood hCG testing starting 24 hours after your initial hCG level. Urine testing will be done at home each morning, limiting water intake for at least 8 hours beforehand.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your urine and serum b-hCG levels will be measured for 7 days.
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MIRA CONNECT Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Inclusion
Exclusion
What this trial measures
- Urine b-hCG7 days
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.
- Serum b-hCG7 days
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.