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

NCT07519954 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2026-08-18

No results posted yet for this study

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. 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.

Conditions

  • Pregnancy of Unknown Location (PUL)

Interventions

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.

Sponsors & Collaborators

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-03-01
Completion
2028-10-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07519954 on ClinicalTrials.gov