[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100356620":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":70,"collaborators":74,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":10,"enrollmentInfo":91,"targetDuration":94,"studyType":95,"phases":10,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnant Mothers with Opioid Use Disorder",null,"Planned recruitment of 200 pregnant (\\\u003C16weeks) mothers who have opioid use disorder and are taking buprenorphine",[13,14,15],"Drug: Subutex \u002F Buprenorphine","Diagnostic Test: Fetal & Neonatal MRI","Diagnostic Test: DNA\u002FGenetic\u002FPharmacokenetic Blood Draws",{"label":17,"type":10,"description":18,"interventionNames":19},"Pregnant Mothers","Planned recruitment of 100 pregnant (\\>16weeks) mothers who do not have any history of opioid use disorder.",[14,15],[21,26,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DRUG","Subutex \u002F Buprenorphine","Pregnant Mothers must be taking buprenorphine \u002F subutex for opioid use disorder.",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"DIAGNOSTIC_TEST","Fetal & Neonatal MRI","Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.",[17,9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"DNA\u002FGenetic\u002FPharmacokenetic Blood Draws","Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples.",[17,9],[36],{"name":37,"affiliation":38,"role":39},"Senthil Sadhasivam, MD, MPH","University of Pittsburgh, UPMC","PRINCIPAL_INVESTIGATOR",[41,45],{"name":37,"role":42,"phone":43,"phoneExt":10,"email":44},"CONTACT","4126474484","sadhasivams@upmc.edu",{"name":46,"role":42,"phone":47,"phoneExt":10,"email":48},"Carly Riedmann, MPH","4126234147","riedmannca@upmc.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"UPMC Children's Hospital","RECRUITING","Pittsburgh","Pennsylvania","15224","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-79.99589,40.44062,{"lat":62,"lon":61},[65,67,68],{"name":66,"role":42,"phone":43,"phoneExt":10,"email":44},"Senthil M Sadhasivam, MD, MPH",{"name":46,"role":42,"phone":47,"phoneExt":10,"email":48},{"name":69,"role":39,"phone":10,"phoneExt":10,"email":10},"Senthilkumar Sadhasivam, MD, MPH",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Senthil Sadhasivam","Professor",[75,78],{"name":76,"class":77},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":79,"class":77},"National Institute on Drug Abuse (NIDA)","100356620","opioid-use-disorder-in-pregnancy-in-long-term-maternalinfant-outcomes-100356620",false,"NCT03923374","Opioid Use Disorder in Pregnancy in Long-Term Maternal\u002FInfant Outcomes","Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal\u002FInfant Outcomes","Mother\u002FBabyOUD","Inclusion Criteria:\n\n* Age greater 18 years\n* Currently taking Buprenorphine for Opioid Use Disorder and enrolled in a prenatal opioid maintenance program in the antenatal clinic at IU Health University Hospital.\n* Pregnant with single baby\n* Planned delivery at Methodist, University or Riley Hospital\n\nExclusion Criteria:\n\n* Serious maternal medical illness as deemed by study physician or investigator.\n* Known or suspected major fetal\u002Fneonatal congenital abnormalities.",true,"FEMALE","18 Years",{"count":92,"type":93},600,"ESTIMATED","2 Years","OBSERVATIONAL","The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).",[98,99,100],"Opioid-use Disorder","Opioid Use, Unspecified","Buprenorphine Dependence",[102,103,104,105,106],"Pregnant with Opioid Use Disorder","Opioid Use Disorder ( OUD)","Subutex","Buprenorphine","Pregnant taking buprenorphine\u002Fsubutex","2025-12-16",{"date":109,"type":110},"2025-12-18","ACTUAL",{"date":112,"type":110},"2018-09-15",{"date":114,"type":93},"2026-12-30",{"name":72,"class":6},1]