[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625065":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":36,"armGroups":37,"interventions":48,"overallOfficials":58,"centralContacts":65,"locations":74,"responsibleParty":119,"collaborators":121,"id":134,"slug":32,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":135,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":32,"studyType":147,"phases":32,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":107,"whyStopped":32,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"University of Edinburgh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":32},[9,13],{"measure":10,"description":11,"timeFrame":12},"Sensitivity","Sensitivity of percentage change in Human Chorionic Gonadotropin (HCG) between Day 0 and Day2-4 compared with percentage change in Human Chorionic Gonadotropin (HCG) between Day 0 and Day 7","Day 0, Day 2-4 and Day 7",{"measure":14,"description":15,"timeFrame":16},"Specificity","The Specificity of percentage HCG drop between Day 0 and Day 2-4, compared with specificity of percentage HCG drop between Day 0 and Day 7","7 days",[18,22,26,29],{"measure":19,"description":20,"timeFrame":21},"Usability questionnaire for Human Chorionic Gonadotropin (HCG) POCT verification using Likert scale.","Assess how useful, easy to use, easy to learn to use and acceptable the point of care test is to staff members. Scale will be a minimum of 1 and maximum of 5, with 1 relating to strongly disagree and 5 relating strongly agree to a range of positive statements, meaning a higher score would be a better outcome","1 year",{"measure":23,"description":24,"timeFrame":25},"Positive Predictive Value (PPV)","PPV for complete abortion of the HCG results between Day 2 and Day 4","4 days",{"measure":27,"description":28,"timeFrame":25},"Negative Predictive Value (NPV)","NPV for complete abortion for HCG results day 2-day 4",{"measure":30,"description":31,"timeFrame":16},"Binary Outcome","Whether the patients preferred follow up on Day 2-4 or on Day 7",null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":35,"maskingInfo":32},"COHORT","PROSPECTIVE","Those having an abortion who meet the currently accepted clinical criteria for very early medical abortions.",[38,44],{"label":39,"type":32,"description":40,"interventionNames":41},"VEMA Patients","Women \\& Gender diverse individuals meeting clinical requirements for having very early medical abortion",[42,43],"Diagnostic Test: Blood test","Other: Participant Questionnaire",{"label":45,"type":32,"description":46,"interventionNames":47},"Staff Members","Staff members involved in using the point of care test",[43],[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":32},"DIAGNOSTIC_TEST","Blood test","Patients will undergo one additional blood test than is usual with standard care, to measure Human Chorionic Gonadotropin (HCG) level which will be analysed on a point of care test machine and in the lab",[39],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":32},"Participant Questionnaire","The investigators will administer participant questionnaires to both staff and patients to understand opinions on the point of care test machine",[45,39],[59,63],{"name":60,"affiliation":61,"role":62},"Sharon Cameron","NHS Lothian","PRINCIPAL_INVESTIGATOR",{"name":64,"affiliation":5,"role":62},"John Reynolds-Wright",[66,71],{"name":67,"role":68,"phone":69,"phoneExt":32,"email":70},"Jacqueline Quinn","CONTACT","+44 0131 536 1542","chalmers.research@ed.ac.uk",{"name":72,"role":68,"phone":32,"phoneExt":32,"email":73},"Chalmers Centre Research Team Generic Email address","Chalmers.research@ed.ac.uk",[75,92,105],{"facility":76,"status":77,"city":78,"state":32,"zip":32,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"University of Gothenberg","NOT_YET_RECRUITING","Gothenburg","Sweden","SE",{"type":82,"coordinates":83},"Point",[84,85],11.96679,57.70716,{"lat":85,"lon":84},[88],{"name":89,"role":68,"phone":90,"phoneExt":32,"email":91},"Tagrid Jar-Allah","+46 031-343 42 16","tagrid.jar-allah@gu.se",{"facility":93,"status":77,"city":94,"state":32,"zip":32,"country":79,"countryCode":80,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Karolinska Institutet","Stockholm",{"type":82,"coordinates":96},[97,98],18.06871,59.32938,{"lat":98,"lon":97},[101],{"name":102,"role":68,"phone":103,"phoneExt":32,"email":104},"Karin Rebecka Brandell","+46 08-524 864 00","karin.brandell@ki.se",{"facility":106,"status":107,"city":108,"state":32,"zip":32,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Chalmers Sexual Health Clinic","RECRUITING","Edinburgh","United Kingdom","UK",{"type":82,"coordinates":112},[113,114],-3.19648,55.95206,{"lat":114,"lon":113},[117],{"name":67,"role":68,"phone":118,"phoneExt":32,"email":70},"+4401315361542",{"type":120,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[122,125,127,128,130,132],{"name":123,"class":124},"NORDIC pharma (funding)","UNKNOWN",{"name":61,"class":126},"OTHER_GOV",{"name":93,"class":6},{"name":129,"class":6},"Karolinska University Hospital",{"name":131,"class":6},"Göteborg University",{"name":133,"class":6},"Sahlgrenska University Hospital","100625065",false,"NCT07417787","Point of Care Tests in the Management of Very Early Medical Abortion","Point of Care Testing for Human Chorionic Gonadotropin (HCG) to Improve Access to Very Early Medical Abortion and Simplify the Follow up Process","POCT VEMA","Inclusion Criteria:\n\n* Positive pregnancy test\n* Less than six weeks gestation based upon Last Menstrual Period (LMP)\n* No evidence of definite intrauterine pregnancy on ultrasound\n* No signs or symptoms or significant risk factors for ectopic\n* Wish to proceed to VEMA (Very Early Medical Abortion)\n* Available for usual clinical follow up\n* Willing to attend for serum Human Chorionic Gonadotropin (HCG) on two occasions Day 2-4 and Day 7 post mifepristone\n* Written informed consent\n\nExclusion Criteria:\n\n* Pain and\u002For bleeding\n* Significant risk factors for ectopic (previous ectopic, sterilisation, tubal disease, intrauterine device in situ)\n* Suspicious features for ectopic on ultrasound (adnexal mass, moderate free fluid)\n* Unable to provide blood sample\n* Lack of Capacity to consent","FEMALE","16 Years","55 Years",{"count":145,"type":146},130,"ESTIMATED","OBSERVATIONAL","This study will investigate the use of a point of care test in patients who are having an abortion at a gestation of \\\u003C6 weeks (known as a very early medical abortion). These patients have pregnancy hormone level checked at Day 0 and Day 7 to see if treatment has worked. The investigators plan to use a point of care test machine to see if it is possible to check pregnancy hormone level earlier than Day 7.",[150],"Abortion Early",[152,153,154,155],"VEMA","Very Early Medical Abortion","point of care test","POCT","2026-06-01",{"date":158,"type":159},"2026-06-03","ACTUAL",{"date":161,"type":159},"2026-04-23",{"date":163,"type":146},"2028-02",{"name":5,"class":6},3]