Expediting Pregnancy of Unknown Location Risk Stratification Using the ROM-Plus Point of Care Test
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ROM-Plus bedside test.
- Who it may be relevant to
- Registry conditions: Pregnancy of Unknown Location (PUL). Basic parameters: from 15 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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
Primary outcome measures
- sensitivity [Time frame: at time of enrollment]
Secondary outcome measures (3)
- specificity [Time frame: at time of enrollment]
- Positive predictive value [Time frame: at the time of enrollment]
- Negative predictive value [Time frame: at the time of enrollment]
Eligibility criteria
Inclusion criteria
- PUL diagnosis in the UC Davis Emergency Department or Obstetrics and Gynecology Office
- Vaginal bleeding
- Clinically stable
- English-speaking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07519954 · 2397064 · not yet available