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MIRA CONNECT Study

RecruitingHealthy volunteers welcome

Assessing Accuracy and Precision of Home Quantitative Urine Beta hCG With Serum for Pregnancy of Unknown Location (CONNECT)

Who can join

Ages 18 to 40 · Women · Healthy volunteers welcome

Full 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

About the study

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).

What is being tested

Sponsor: University of Colorado, Denver · Participants: 35 · Started: Jun 1, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06802263

Locations in the U.S.

ColoradoUniversity of Colorado, Aurora

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.