[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539123":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":87,"collaborators":10,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":10,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":10,"maxAge":10,"enrollmentInfo":97,"targetDuration":100,"studyType":101,"phases":10,"briefSummary":102,"conditions":103,"keywords":10,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"argenx","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Retrospective Pregnancy",null,"woman is no longer pregnant at time of study enrollment but was exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy",[13],"Biological: Efgartigimod",{"label":15,"type":10,"description":16,"interventionNames":17},"Prospective Pregnancy","woman is pregnant or breastfeeding at time of study enrollment.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"BIOLOGICAL","Efgartigimod","Efgartigimod IV or SC",[15,9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Sabine Coppieters, MD","CONTACT","857-350-4834","Clinicaltrials@argenx.com",[31,48,61,74],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"United BioSource LLC","RECRUITING","Morgantown","West Virginia","26508","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-79.9559,39.62953,{"lat":43,"lon":42},[46],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":47},"clinicaltrials@argenx.com",{"facility":49,"status":33,"city":50,"state":10,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre Infusionsambulanz + MS Studienambulanz (Haus E Ebene1)","Bochum","44791","Germany","DE",{"type":40,"coordinates":55},[56,57],7.21648,51.48165,{"lat":57,"lon":56},[60],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":47},{"facility":62,"status":33,"city":63,"state":10,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Roma","00168","Italy","IT",{"type":40,"coordinates":68},[69,70],11.10642,44.99364,{"lat":70,"lon":69},[73],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":47},{"facility":75,"status":33,"city":76,"state":10,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Hospital Universitari Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":40,"coordinates":81},[82,83],2.15899,41.38879,{"lat":83,"lon":82},[86],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":47},{"type":88,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100539123","a-worldwide-pregnancy-safety-study-to-assess-maternal-fetal-and-infant-outcomes-following-exposure-to-efgartigimod-during-pregnancy-andor-breastfeeding-100539123",false,"NCT06299748","A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and\u002For Breastfeeding.","A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And\u002FOr Breastfeeding","Inclusion Criteria:\n\n* Women with exposure to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod PH20 SC during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days.\n* Written\u002Fverbal informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written\u002Fverbal informed assent or eConsent by the pregnant minor (where applicable) and written\u002Fverbal informed consent or eConsent by the parent\u002Flegal guardian).\n\nExclusion Criteria:\n\n* None","FEMALE",{"count":98,"type":99},279,"ESTIMATED","1 Year","OBSERVATIONAL","This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries\u002Fregions as the countries\u002Fregions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.",[104,105],"Myasthenia Gravis","CIDP - Chronic Inflammatory Demyelinating Polyneuropathy","2026-02-13",{"date":108,"type":109},"2026-02-17","ACTUAL",{"date":111,"type":109},"2023-11-30",{"date":113,"type":99},"2033-12",{"name":5,"class":6},4]