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.

NCT Number	NCT07519954
Lead Sponsor	University of California, Davis Collaborators: Laborie Medical Technologies Inc.
Conditions	Pregnancy of Unknown Location (PUL)
Enrollment	122 participants
Start Date	2026-06-01
Primary Completion	2028-03-01 (estimated)
Study Completion	2028-10 (estimated)
Updated on ClinicalTrials.gov	2026-05-06