Assessing Accuracy and Precision of Home Quantitative Urine Beta hCG With Serum for Pregnancy of Unknown Location (CONNECT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Urine b-hCG
Study Overview
Brief 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).
Detailed Description
This study proposes to test the ability of the Mira urine hCG testing kit to accurately and precisely quantify urine beta hCG testing in women with PUL, thus preventing unnecessary travel time to medical care, time lost from work, costs of childcare services, anxiety, and lack of adherence to medical recommendations.
Aim 1: Assess the accuracy and precision of an at-home quantitative urine b-hCG test in the management of pregnancy of unknown location (PUL). Hypothesis: The Mira quantitative home urine pregnancy test will accurately and precisely quantify beta hCG levels in patients with PUL.
Approach: The study team will recruit 30 women with a diagnosed pregnancy of unknown location (cases) and non-pregnant 5 controls. Potential participants may be identified in the emergency department (ED), inpatient floor, or University of Colorado Health (UC Health) or School of Medicine (CU Medicine) outpatient clinics. Once a diagnosis of PUL is established, cases will be provided with a Mira home testing device.
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •for controls:
- •Non-pregnant
- •Inclusion Criteria for cases:
- •Diagnosed with PUL requiring ongoing surveillance of serum hCG levels
Exclusion Criteria
- •for controls:
- •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
- •Exclusion Criteria for cases:
- •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
Outcomes
Primary Outcomes
Urine b-hCG
Time Frame: 7 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-hCG
Time Frame: 7 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.
Secondary Outcomes
No secondary outcomes reported