At-home urine test for managing pregnancy of unknown location
Official title: Assessing Accuracy and Precision of Home Quantitative Urine Beta hCG With Serum for Pregnancy of Unknown Location (CONNECT)
Run by University of Colorado, Denver · NCT06802263 · Data updated 2026-11-12
This study is testing an at-home urine test for women with pregnancy of unknown location to see if it can accurately track hormone levels and reduce the need for extra doctor visits.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 35 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | March 2, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | September 16, 2025 |
| Trial ID | NCT06802263 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include women diagnosed with pregnancy of unknown location who require ongoing monitoring of their hCG levels.
✕Probably not a fit
Patients with unstable conditions or those with initial serum hCG levels greater than 100,000 mIU/ml may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to evaluate the accuracy and precision of an at-home quantitative urine beta hCG (b-hCG) test for women diagnosed with pregnancy of unknown location (PUL). Participants will use the Mira urine hCG testing kit to monitor their hormone levels, which may help reduce unnecessary medical visits and associated costs. The study will involve 30 women with PUL and 5 non-pregnant controls, with testing occurring daily for up to 7 days. The results will be compared to serum hCG levels measured at a laboratory to assess the test's effectiveness.
Why it matters
Potential benefit: If successful, this approach could provide a convenient and accurate method for women to manage PUL at home, reducing anxiety and healthcare costs.
How similar studies have gone: While the use of at-home testing for pregnancy management is gaining interest, this specific approach for PUL is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Colorado
Aurora, Colorado, United States Recruiting
Study contacts
- Study coordinator: Cara Clure, MD
- Email: CARA.CLURE@CUANSCHUTZ.EDU
- Phone: 720-445-6396
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Office hysteroscopy to diagnose and treat a pregnancy of unknown location
This will test whether office hysteroscopy can safely diagnose and sometimes treat early pregnancies not visible on ultrasound in people with a pregnancy of unknown location.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.