Assessing accuracy and precision of home quantitative urine beta hCG with serum for pregnancy of unknown location (CONNECT).

Primary Objective

This study is being done to assess the accuracy of an at-home urine test for the management of Pregnancy of Unknown Location (PUL).

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Description

The current management of patients with PUL involves multiple trips to the clinic and/or hospital for blood draws and close monitoring of their pregnancy. Specifically, doctors are monitoring levels of a hormone called human Chorionic Gonadotropin (hCG). The hCG can be detected in blood and urine in early pregnancy, and hCG will rise as pregnancy progresses. This study is evaluating the use of the Mira Device in the monitoring of patients with a PUL. Mira is an at-home, lab-grade hormone tracking system that can monitor hCG levels in the urine. If the at-home urine testing proves to be accurate in monitoring hormone levels in patients with PUL, then there is the potential to reduce the number of visits and blood draws required of patients with a PUL.

Details
Age
Adult
Eligibility
a. Cases 1. Female 2. Age: 18 to 40 years 3. Diagnosed with Pregnancy of Unknown Location requiring ongoing surveillance of serum hCG levels b. Controls 1. Female 2. Age: 18 to 40 years 3. Non-pregnant a. Cases i. Inclusion criteria: 1. Female 2. Age: 18 to 40 years 3. Diagnosed with PUL requiring ongoing surveillance of serum hCG levels ii. Exclusion criteria: 1. History of renal disease 2. History of type I or type II diabetes 3. Known malignancy of any diagnosis including hCG-secreting tumors (hepatobiliary tumors and neuroendocrine tumors) and ovarian germ cell tumors. 4. Gestational Trophoblastic Disease 5. Unstable patient, concern for ruptured ectopic pregnancy 6. Initial serum hCG level > 100,000 mIU/ml b. Controls i. Inclusion criteria: 1. Female 2. Age: 18 to 40 years 3. Non-pregnant ii. Exclusion criteria: 1. History of renal disease 2. History of type I or type II diabetes 3. Known malignancy of any diagnosis including hCG-secreting tumors (hepatobiliary tumors and neuroendocrine tumors) and ovarian germ cell tumors. 4. Gestational Trophoblastic Disease 5. Use of hormonal contraception within last 3 months 6. Patients who work the night shift
Locations

University of Colorado Hospital

Principal Investigator
Photograph of Leslie Appiah

Leslie Appiah

Study ID

Protocol Number: 22-1954

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