[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100357614":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":54,"collaborators":56,"id":59,"slug":10,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":10,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Regeneron Pharmaceuticals","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Dupilumab cohort",null,"Exposed to dupilumab during the relevant exposure window:\n\n* First trimester\n* Pregnancy",[13],"Drug: dupilumab",{"label":15,"type":10,"description":16,"interventionNames":10},"Other systemic therapy or phototherapy cohort","Exposed to systemic medications other than dupilumab or to phototherapy during the relevant exposure window:\n\n* First trimester\n* Pregnancy",{"label":18,"type":10,"description":19,"interventionNames":10},"Unexposed cohort","* Not exposed to systemic medications (including dupilumab) or phototherapy; and\n* Received topical prescription therapy, or a second diagnosis for AD on a date that differs from the base population qualifying AD diagnosis date during the relevant exposure window:\n* First trimester\n* Pregnancy",[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","dupilumab","No study drug will be administered. This study is based on an analysis of automated medical and prescription claims, supplemented by information abstracted from the medical record.",[9],[27,28,29],"REGN668","Dupixent®","SAR23189",[31],{"name":32,"affiliation":5,"role":33},"Clinical Trial Management","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":10},"Regeneron Research Site","RECRUITING","Boston","Massachusetts","02215","United States",{"type":49,"coordinates":50},"Point",[51,52],-71.05977,42.35843,{"lat":52,"lon":51},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57],{"name":58,"class":6},"Sanofi","100357614",false,"NCT03936335","An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)","Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)","Key Inclusion Criteria:\n\n* Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated LMP\n* Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy\n\nNote: Other Protocol Defined Inclusion \u002F Exclusion Criteria Apply","FEMALE","18 Years","49 Years",{"count":69,"type":70},3930,"ESTIMATED","OBSERVATIONAL","The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion\u002Fmiscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations \\[MCMs\\], small for gestational age \\[SGA\\]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.",[74,75],"Adverse Pregnancy Outcomes","Atopic Dermatitis","2025-07-30",{"date":78,"type":79},"2025-08-03","ACTUAL",{"date":81,"type":79},"2019-09-30",{"date":83,"type":70},"2027-01-21",{"name":5,"class":6},1]