Expediting Pregnancy of Unknown Location Risk Stratification Using the ROM-Plus Point of Care Test

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy of Unknown Location (PUL)
• Intervention / Treatment: Diagnostic test: ROM-Plus bedside test

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 Type: Observational
• Enrollment (Estimated): 122

Contacts and Locations

• Study Contact: Name: Anne Flynn, MD, MSHP; Phone Number: 916-734-6900; Email: aenflynn@health.ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• PUL diagnosis in the UC Davis Emergency Department or Obstetrics and Gynecology Office
• Vaginal bleeding
• Clinically stable
• English-speaking

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pregnancy of unknown location; Pregnancy of unknown location with vaginal bleeding

Diagnostic test: ROM-Plus bedside 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity	Sensitivity of ROM-Plus test	at time of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
specificity	specificity of the ROM-Plus test	at time of enrollment
Positive predictive value	Positive predictive value of the ROM-Plus test	at the time of enrollment
Negative predictive value	Negative predictive value of the ROM-Plus test	at the time of enrollment

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Laborie Medical Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ectopic pregnancy; vaginal bleeding; pregnancy of unknown location (PUL); risk-stratification; ROM-Plus test
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Hemorrhage; Pathological Conditions, Signs and Symptoms; Uterine Hemorrhage; Pregnancy, Ectopic
• Other Study ID Numbers: 2397064; not yet available (Other Grant/Funding Number: Laborie)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No