Pregnancy of Unknown Location (PUL)NCT07519954
Expediting Pregnancy of Unknown Location Risk Stratification Using the ROM-Plus Point of Care Test
An observational study of Pregnancy of Unknown Location (PUL), run by University of California, Davis.
Trial summary
The goal of this study is to learn if the ROM-Plus bedside test can effectively triage patients who present with pregnancy of unknown location (PUL) and vaginal bleeding as high or low risk for ectopic pregnancy. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy of Unknown Location (PUL)
- What is being tested?
- ROM-Plus bedside test
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We will prospectively follow patients who present to the Emergency Room or OBGYN clinic and are diagnosed with PUL. In this clinical trial, we will include patients who present with PUL, have vaginal bleeding, and are clinically stable. Patients will be excluded if they have a definitive diagnosis on initial presentation, have an incidental pregnancy identified, or present with cramping only.
Who may be able to join
- PUL diagnosis in the UC Davis Emergency Department or Obstetrics and Gynecology Office
- Vaginal bleeding
- Clinically stable
- English-speaking
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this study is to learn if the ROM-Plus bedside test can effectively triage patients who present with pregnancy of unknown location (PUL) and vaginal bleeding as high or low risk for ectopic pregnancy. The main question to answer is:
Can the ROM-Plus bedside test effectively risk-stratify patients who present with PUL and vaginal bleeding as high or low risk for ectopic pregnancy after a single clinical encounter.
Participants will have a vaginal swab collected at the time of presentation.
Read the detailed description
Pregnancy of unknown location (PUL) is a clinical scenario in which a patient has cramping or vaginal bleeding and is known to be pregnant based on physical and laboratory evaluations, but an intrauterine or extrauterine pregnancy cannot be visualized on ultrasound examination. At present, follow-up for these patients includes multiple blood draws and repeat ultrasounds to confirm if the pregnancy is inside the uterus or in a riskier location outside the uterus (ectopic pregnancy); however, most of these patients will be low-risk for ectopic pregnancy and do not need intensive follow-up. This study aims to improve the risk-stratification of PUL patients after a single encounter to allow for patients at low-risk for ectopic pregnancy to be discharged from intensive follow-up.
Recruitment: Up to 120 participants will be recruited for this study
Entry Criteria:
- PUL diagnosis in the UC Davis Emergency Department or Obstetrics and Gynecology Office
- Vaginal bleeding
- Clinically stable
- English-speaking
Consent - Eligible Patients will be invited to participate by a member of the clinical care team. Written consent will be required.
Confidentiality - The Principal Investigator will preserve the confidentiality of participants taking part in the study. All patient information will be stored on a secure computer with password protection. All information will be de-identified.
Conflict of interest - none
- Conditions
- Pregnancy of Unknown Location (PUL)
- Being tested
- ROM-Plus bedside test
- Keywords
- pregnancy of unknown location (PUL), risk-stratification, ROM-Plus test, ectopic pregnancy, vaginal bleeding
- Medical subject headings
- Pregnancy, Ectopic, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROM-Plus bedside testDiagnostic test
ROM-Plus is a bedside test that detects alpha-fetoprotein (AFP) and insulin-like growth factor binding protein 1 (IGFBP-1) in vaginal blood with a 95.7% sensitivity for confirming an IUP. This test also was found to have a specificity of 97% for identifying patients who had ectopic pregnancies in an exploratory comparative study in which those with an intrauterine pregnancy had a positive test and those with an ectopic (extrauterine) pregnancy had a negative test. However, this test has not been evaluated specifically in PUL patients. The test result will not be provided to the treating clinician/team and will not be used to make clinical decisions.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy of unknown location | Pregnancy of unknown location with vaginal bleeding Receives: Diagnostic Test: ROM-Plus bedside test |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
Sensitivity of ROM-Plus test
Measured: at time of enrollment
Secondary outcomes (3)
specificity
specificity of the ROM-Plus test
Measured: at time of enrollment
Positive predictive value
Positive predictive value of the ROM-Plus test
Measured: at the time of enrollment
Negative predictive value
Negative predictive value of the ROM-Plus test
Measured: at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy of Unknown Location (PUL)Studies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Laborie Medical Technologies Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519954
- Sponsor's protocol ID
- 2397064
- Other IDs
- not yet available
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expediting Pregnancy of Unknown Location Risk Stratification Using the ROM-Plus Point of Care Test
- ClinicalTrials.gov ID
- NCT07519954
- Acronym / sponsor ID
- 2397064
- Conditions
- Pregnancy of Unknown Location (PUL)
- Keywords
- pregnancy of unknown location (PUL), risk-stratification, ROM-Plus test, ectopic pregnancy, vaginal bleeding
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Laborie Medical Technologies Inc.
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn if the ROM-Plus bedside test can effectively triage patients who present with pregnancy of unknown location (PUL) and vaginal bleeding as high or low risk for ectopic pregnancy. The main question to answer is:
Can the ROM-Plus bedside test effectively risk-stratify patients who present with PUL and vaginal bleeding as high or low risk for ectopic pregnancy after a single clinical encounter.
Participants will have a vaginal swab collected at the time of presentation.
Detailed description
Pregnancy of unknown location (PUL) is a clinical scenario in which a patient has cramping or vaginal bleeding and is known to be pregnant based on physical and laboratory evaluations, but an intrauterine or extrauterine pregnancy cannot be visualized on ultrasound examination. At present, follow-up for these patients includes multiple blood draws and repeat ultrasounds to confirm if the pregnancy is inside the uterus or in a riskier location outside the uterus (ectopic pregnancy); however, most of these patients will be low-risk for ectopic pregnancy and do not need intensive follow-up. This study aims to improve the risk-stratification of PUL patients after a single encounter to allow for patients at low-risk for ectopic pregnancy to be discharged from intensive follow-up.
Recruitment: Up to 120 participants will be recruited for this study
Entry Criteria:
- PUL diagnosis in the UC Davis Emergency Department or Obstetrics and Gynecology Office
- Vaginal bleeding
- Clinically stable
- English-speaking
Consent - Eligible Patients will be invited to participate by a member of the clinical care team. Written consent will be required.
Confidentiality - The Principal Investigator will preserve the confidentiality of participants taking part in the study. All patient information will be stored on a secure computer with password protection. All information will be de-identified.
Conflict of interest - none
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy of unknown location | – | Diagnostic Test: ROM-Plus bedside testPregnancy of unknown location with vaginal bleeding |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will prospectively follow patients who present to the Emergency Room or OBGYN clinic and are diagnosed with PUL. In this clinical trial, we will include patients who present with PUL, have vaginal bleeding, and are clinically stable. Patients will be excluded if they have a definitive diagnosis on initial presentation, have an incidental pregnancy identified, or present with cramping only.
Key inclusion criteria (4 listed)
- PUL diagnosis in the UC Davis Emergency Department or Obstetrics and Gynecology Office
- Vaginal bleeding
- Clinically stable
- English-speaking
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROM-Plus bedside testROM-Plus is a bedside test that detects alpha-fetoprotein (AFP) and insulin-like growth factor binding protein 1 (IGFBP-1) in vaginal blood with a 95.7% sensitivity for confirming an IUP. This test also was found to have a specificity of 97% for identifying patients who had ectopic pregnancies in an exploratory comparative study in which those with an intrauterine pregnancy had a positive test and those with an ectopic (extrauterine) pregnancy had a negative test. However, this test has not been evaluated specifically in PUL patients. The test result will not be provided to the treating clinician/team and will not be used to make clinical decisions. | Diagnostic test | Pregnancy of unknown location |
Primary outcome
sensitivity
Time frame: at time of enrollment
Sensitivity of ROM-Plus test
3 secondary outcomes
specificity
Time frame: at time of enrollment
Positive predictive value
Time frame: at the time of enrollment
Negative predictive value
Time frame: at the time of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pregnancy of Unknown Location (PUL)
Recruiting
MIRA CONNECT Study
Pregnancy of Unknown Location (PUL)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy of Unknown Location (PUL), run by University of California, Davis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Flynn, MD, MSHP (916-734-6900, aenflynn@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: at time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.