Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07519954

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

ROM-Plus bedside test

Diagnostic 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.

Primary outcomes

  1. sensitivity

    Time frame: at time of enrollment

    Sensitivity of ROM-Plus test

Secondary outcomes

  1. specificity

    Time frame: at time of enrollment

    specificity of the ROM-Plus test

  2. Positive predictive value

    Time frame: at the time of enrollment

    Positive predictive value of the ROM-Plus test

  3. Negative predictive value

    Time frame: at the time of enrollment

    Negative predictive value of the ROM-Plus test

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Flynn, MD, MSHP

CONTACT

[email protected]

916-734-6900

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Laborie Medical Technologies Inc.

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.