An observational study in Pregnancy of Unknown Location (PUL), sponsored by University of California, Davis. Not yet recruiting. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of California, Davis · Observational
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.
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:
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
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.
Inclusion Criteria:
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.
sensitivity
Sensitivity of ROM-Plus test
Time frame: at time of enrollment
specificity
specificity of the ROM-Plus test
Time frame: at time of enrollment
Positive predictive value
Positive predictive value of the ROM-Plus test
Time frame: at the time of enrollment
Negative predictive value
Negative predictive value of the ROM-Plus test
Time frame: at the time of enrollment
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of California, Davis