[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632920":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":10,"responsibleParty":26,"collaborators":28,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":10,"eligibilityCriteria":37,"healthyVolunteers":38,"sex":39,"minAge":40,"maxAge":10,"enrollmentInfo":41,"targetDuration":10,"studyType":44,"phases":10,"briefSummary":45,"conditions":46,"keywords":48,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":10},{"fullName":5,"class":6},"University of California, Davis","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnancy of unknown location",null,"Pregnancy of unknown location with vaginal bleeding",[13],"Diagnostic Test: ROM-Plus bedside test",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"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\u002Fteam and will not be used to make clinical decisions.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Anne Flynn, MD, MSHP","CONTACT","916-734-6900","aenflynn@health.ucdavis.edu",{"type":27,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[29],{"name":30,"class":31},"Laborie Medical Technologies Inc.","INDUSTRY","100632920","expediting-pregnancy-of-unknown-location-risk-stratification-using-the-rom-plus-point-of-care-test-100632920",false,"NCT07519954","Expediting Pregnancy of Unknown Location Risk Stratification Using the ROM-Plus Point of Care Test","Inclusion Criteria:\n\n* PUL diagnosis in the UC Davis Emergency Department or Obstetrics and Gynecology Office\n* Vaginal bleeding\n* Clinically stable\n* English-speaking",true,"FEMALE","15 Years",{"count":42,"type":43},122,"ESTIMATED","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:\n\nCan 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.\n\nParticipants will have a vaginal swab collected at the time of presentation.",[47],"Pregnancy of Unknown Location (PUL)",[49,50,51,52,53],"pregnancy of unknown location (PUL)","risk-stratification","ROM-Plus test","ectopic pregnancy","vaginal bleeding","NOT_YET_RECRUITING","2026-08-15",{"date":57,"type":58},"2026-08-18","ACTUAL",{"date":60,"type":43},"2026-10-01",{"date":62,"type":43},"2028-10",{"name":5,"class":6}]