| NCT ID | NCT06802263 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Pregnancy of Unknown Location (PUL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2027-03-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2024-06-01 with a primary completion date of 2027-03-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06802263 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Pregnancy of Unknown Location (PUL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06802263 currently recruiting?
Yes, NCT06802263 is actively recruiting participants. Contact the research team at CARA.CLURE@CUANSCHUTZ.EDU for enrollment information.
Where is the NCT06802263 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06802263 clinical trial?
NCT06802263 is sponsored by University of Colorado, Denver. The trial plans to enroll 35 participants.