Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06802263

Conditions

Pregnancy of Unknown Location (PUL)

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

at-home quantitative urine b-hCG test

Study Details

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).

Conditions

Pregnancy of Unknown Location (PUL)

Study ID

NCT06802263

Start date

Jun 1, 2024

Status verified date

Sep, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Mar 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

35 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

sham comparator: CNTRL: Non-pregnant control patients

Non-pregnant patients will use the pregnancy test device

active comparator: PUL: Pregnancy unknown location diagnosis

Pregnant patients with unknown location diagnosis will use the pregnancy test device

Interventions

at-home quantitative urine b-hCG test

Cases will begin performing urine and serum hCG testing 24 hours after the initial hCG level. Urine hCG testing will be performed on the first morning urine at home and participants will limit water for at least 8 hours before testing. Serum hCG testing will occur at a UCHealth laboratory before 10 am and within 2 hours of the urine test to allow for the comparison of the values. Both urine and serum hCG testing will then occur daily x 7 days, or until a medical or surgical intervention is indicated. If serum testing is indicated on a weekend, patients will present to the UCH Infusion Center.

Non-pregnant controls will test the first morning urine at home and undergo serum hCG testing in a UCHealth lab on the 4th and 6th day of the menstrual cycle. All urine hCG values will be recorded in the Mira home kit and evaluated in comparison to serum hCG levels.

Primary outcome measure

  • Urine b-hCG [ Time Frame: 7 days ]
  • Serum b-hCG [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Cara Clure, MD

720-445-6396CARA.CLURE@CUANSCHUTZ.EDU

Jocelyn Phipers, NP

303-724-7807Jocelyn.Phipers@cuanschutz.edu

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Cara Clure, MD

720-445-6396CARA.CLURE@CUANSCHUTZ.EDU

Jocelyn Phipers, NP

303-724-7807Jocelyn.Phipers@cuanschutz.edu

Principal Investigator:

Cara Clure, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 16, 2025

Last verified

Sep, 2025

Keywords

  • pregnancy
  • unknown location
  • b-hCG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-09-16.