At-home urine test for managing pregnancy of unknown location
Assessing Accuracy and Precision of Home Quantitative Urine Beta hCG With Serum for Pregnancy of Unknown Location (CONNECT)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06802263 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women diagnosed with pregnancy of unknown location who require ongoing monitoring of their hCG levels.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aurora, Colorado
- University of Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Cara Clure, MD
- Email: CARA.CLURE@CUANSCHUTZ.EDU
- Phone: 720-445-6396
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.