[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586067":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":59,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"CorEvitas","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IBD pharmacotherapy exposed",null,"Individuals with a diagnosis of IBD who are exposed to an approved IBD pharmacotherapy at any time during pregnancy",[13],"Drug: Exposed to IBD pharmacotherapy during pregnancy",{"label":15,"type":10,"description":16,"interventionNames":17},"IBD pharmacotherapy unexposed","Individuals with a diagnosis of IBD who are not exposed to IBD pharmacotherapy during pregnancy",[18],"Other: Non-exposed group",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"OTHER","Non-exposed group","Pregnant individuals with IBD who are not exposed to an IBD pharmacotherapy during pregnancy",[15],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"DRUG","Exposed to IBD pharmacotherapy during pregnancy","Pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy",[9],[31],{"name":32,"affiliation":33,"role":34},"Ronna L Chan, PhD, MPH","PPD, Part of Thermo Fisher Scientific","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":10,"email":39},"CONTACT","800-616-3791","ibd-pr@corevitas.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"PPD","RECRUITING","Wilmington","North Carolina","28401","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-77.94604,34.23556,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":10,"email":39},"CorEvitas Clinical Research Associate","1-800-616-3791",{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100586067","ibd-pregnancy-registry-100586067",false,"NCT06910553","IBD Pregnancy Registry","CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)","IBD-PR","Inclusion Criteria:\n\nExposed and unexposed cohort:\n\n* A resident of the US or Canada at enrollment\n* Currently pregnant\n* 18 to 50 years of age at enrollment\n* Physician-confirmed diagnosis of IBD (UC, CD, other and unspecified noninfective gastroenteritis and colitis \\[ICD-10 K52\\] and indeterminate colitis \\[ICD-10 K52.3\\])\n* Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant institutional review board (IRB)\u002Findependent ethics committee, verbal consent, indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study\n* Authorize their HCP to provide data to the registry\n* Provide contact information (for participant and HCPs)\n\nExposed cohort only:\n\n\\- Exposed to an IBD pharmacotherapy during pregnancy\n\nExclusion Criteria:\n\nExposed and unexposed cohort:\n\n* Exposure to methotrexate during pregnancy","FEMALE","18 Years","50 Years",{"count":73,"type":74},832,"ESTIMATED","OBSERVATIONAL","Data collected through the registry may be used to address a range of research questions and objectives, including but not limited to the following:\n\nResearch question: Is there an increased risk of adverse maternal, fetal, or infant outcomes among individuals who are exposed to Inflammatory Bowel Disease (IBD) treatments during pregnancy?\n\nThe primary objective of the registry is to estimate the prevalence of major congenital malformations among pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy.\n\nThe secondary objectives of the registry are:\n\nTo estimate the prevalence of other maternal, fetal, and infant outcomes among pregnant individuals with IBD who are exposed to IBD pharmacotherapies during pregnancy.\n\nTo contextualize the prevalence of outcomes among pregnant individuals who are exposed to IBD pharmacotherapies during pregnancy and estimate the prevalence of all outcomes of interest among pregnant individuals with IBD who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy.\n\nIf sample size permits, to estimate the risk ratio for each outcome, comparing the outcomes of pregnant individuals with IBD who are exposed to IBD pharmacotherapy with those who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy.\n\nData collection may be used to determine pharmacotherapy-specific use with or without unexposed cohorts on an as-needed basis, as sample size allows.",[78],"Inflammatory Bowel Disease (IBD)",[80,81,82,83,84,85],"Pregnant","IBD","Registry","UC","Inflammatory Bowel Disease","Ulcerative Colitis","2025-04-02",{"date":88,"type":89},"2025-04-04","ACTUAL",{"date":91,"type":74},"2025-04",{"date":93,"type":74},"2032-09",{"name":5,"class":6},1]