MIRA CONNECT Study

Launched by UNIVERSITY OF COLORADO, DENVER · Jan 29, 2025

Keywords

ClinConnect Summary

The MIRA CONNECT Study is a clinical trial that aims to evaluate how well an at-home urine test can measure a hormone called beta hCG (b-hCG) to help manage cases of Pregnancy of Unknown Location (PUL). PUL occurs when a pregnancy is detected, but doctors cannot find where it is located. This study is currently looking for participants, specifically women aged between 6574 and 14609 who have been diagnosed with PUL and need ongoing monitoring of their hCG levels. Non-pregnant women can also participate as controls, but certain health conditions, like kidney disease or cancer, may prevent someone from taking part.

Participants in this study will likely use the at-home urine test to track their hCG levels and report their results. This could help both patients and doctors better understand the situation and decide on the best course of action. It’s important to know that women with certain serious health issues or unstable conditions, such as a suspected ruptured ectopic pregnancy, cannot join this trial. Overall, the study aims to provide valuable insights into managing PUL effectively and safely from home.

Gender

FEMALE

Eligibility criteria

• 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