NCT07519954

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 122 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Accepted

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.

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)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-03-01
• Completion: 2028-10-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Regulatory

• FDA-regulated device study