[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100346295":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":10,"locations":23,"responsibleParty":29,"collaborators":31,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":10,"eligibilityCriteria":40,"healthyVolunteers":41,"sex":42,"minAge":10,"maxAge":10,"enrollmentInfo":43,"targetDuration":10,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":10,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":59},{"fullName":5,"class":6},"LEO Pharma","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnant women exposed to glucocorticoids",null,"Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy",[13],"Drug: Diflucortolone valerate (BAY866146)",{"label":15,"type":10,"description":16,"interventionNames":10},"Non-exposed pregnant women","Women not using any glucocorticoid or corticosteroid or steroids during pregnancy",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DRUG","Diflucortolone valerate (BAY866146)","Follow clinical administration",[9],[24],{"facility":25,"status":10,"city":26,"state":10,"zip":10,"country":27,"countryCode":28,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Many locations","Multiple Locations","Germany","DE",{"type":30,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[32],{"name":33,"class":6},"Bayer","100346295","a-study-to-learn-more-about-the-relationship-between-the-development-of-a-gap-in-the-upper-lip-cleft-lip-or-in-the-roof-of-the-mouth-cleft-palate-in-newborns-and-the-use-of-glucocorticoids-by-the-mother-during-pregnancy-a-meta-analysis-100346295",false,"NCT03788863","A Study to Learn More About the Relationship Between the Development of a Gap in the Upper Lip (Cleft Lip) or in the Roof of the Mouth (Cleft Palate) in Newborns and the Use of Glucocorticoids by the Mother During Pregnancy: a Meta-analysis","Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis","Inclusion Criteria:\n\n* Population: Pregnant women\n* Intervention: Any glucocorticoid or corticosteroid or steroids use irrespective of mode of administration\n* Comparator: Any\u002Fnone\n* Outcomes: Incidence\u002F risk of cleft lip\u002Fpalate in infants\n* Study Design:\n\n  * Meta-analysis and systematic literature reviews\n  * Observational studies (such as cohort study, case-control study, registries data)\n  * Clinical trials - Phase IIb, III, and IV\n  * Conference abstracts\u002Fposters\n* Time period: No time period restriction\n* Geography: No geography restriction\n\nExclusion Criteria:\n\n* Population: Nonpregnant women\n* Intervention: Drugs other than glucocorticoid or corticosteroid or steroid\n* Outcomes: Incidence\u002F risk of cleft lip\u002Fpalate in infants\n* Study Design:\n\n  * Animal Study\n  * In vitro studies\n  * Editorial, letters, comment\n  * Clinical trials - Phase I or preclinical\n  * Case reports, case series\n  * Reviews\n* Studies focusing on:\n\n  * Diagnosis and surgical procedure for cleft repair\n  * Impact of Increased internal corticosteroids due to stress\n  * The relationship between genetic mutations and cleft patients\n  * Adverse events for other drugs\n  * Safety profiles of glucocorticoid or corticosteroid",true,"FEMALE",{"count":44,"type":45},99999,"ACTUAL","OBSERVATIONAL","Glucocorticoids are drugs that have many effects on body metabolism, raise sugar level in the blood, and reduce inflammation. By applying a statistical technique for combining the findings from a systematic literature review (meta analysis), researchers want to learn more about the relationship of the risk to develop a separation in the roof of the mouth (cleft palate) in newborns and contact with glucocorticoids during pregnancy.",[49],"Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development","COMPLETED","2020-03-30",{"date":53,"type":45},"2020-04-01",{"date":55,"type":45},"2018-11-16",{"date":57,"type":45},"2018-11-29",{"name":5,"class":6},1]