MIRA CONNECT Study (NCT06802263) | Clinical Trial Compass
RecruitingNot Applicable
MIRA CONNECT Study
United States35 participantsStarted 2024-06-01
Plain-language 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).
Who can participate
Age range18 Years – 40 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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