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Could a simple home urine test replace daily clinic visits for pregnancy of unknown location?

NCT ID NCT06802263

Diagnosis Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study is testing whether an at-home urine test can accurately measure hCG levels in women with a pregnancy of unknown location (PUL). Participants will collect their first morning urine at home and compare it to a blood test done at a lab. If the home test proves accurate, it could allow women to monitor their condition from home, reducing the need for frequent clinic visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
at-home quantitative urine b-hCG test
What this could lead to
If successful, this could allow women with pregnancy of unknown location to monitor their hCG levels at home, reducing the need for daily clinic visits.
What could go wrong
This is a small pilot study with only 35 participants, so results may not apply to everyone. The test requires strict preparation (e.g., limiting water) which may be difficult for some.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pregnancy of unknown location (PUL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

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