[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515606":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":64,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":22,"eligibilityCriteria":71,"healthyVolunteers":68,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":25,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Medical College of Wisconsin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BUNDLE Intervention","EXPERIMENTAL","Proposed components of the intervention will include: 1) attendance at two visits in the 2nd trimester and two visits in the 3rd trimester by a doula; 2) exchange of contact information between the clinic and the doula; 3) exchange of social needs and social-structural risk factors complicating patient's prenatal care from doula and exchange of clinical risk factors complicating prenatal care from obstetric provider; 4) communication between the doula and provider; 5) educating the obstetric team on benefits of doula support; 6) preparing labor and delivery team for presence of doula during labor ; and 7) enhancing doula support postpartum for cardiovascular risk reduction.",[13],"Other: BUNDLE",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","ACTIVE_COMPARATOR","Standard of care for pregnancy and pregnancy-related issues will be provided by the obstetric provider as per routine.",[19],"Other: Usual Care",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BUNDLE","An integrated model of community-based doulas and clinical obstetric providers",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Standard of care for pregnancy and pregnancy-related issues by the obstetric provider",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Anna Palatnik, MD","CONTACT","(414) 805-6624","apalatnik@mcw.edu",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Joni S Williams, MD, MPH","(414) 955-8827","jswilliams@mcw.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Milwaukee","Wisconsin","53226-3522","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-87.90647,43.0389,{"lat":51,"lon":50},[54,58,62],{"name":55,"role":32,"phone":56,"phoneExt":25,"email":57},"Erica Marion, PhD","4148058505","emarion@mcw.edu",{"name":59,"role":32,"phone":60,"phoneExt":25,"email":61},"Alyssa Hernandez, DO","4148055285","alyhernandez@mcw.edu",{"name":31,"role":63,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":31,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Associate Professor","100515606","building-trust-and-uniting-teams-through-doula-partnership---bundle-100515606",false,"NCT05993689","Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE","Inclusion Criteria:\n\n* Self-reported Black or African American\n* Pregnant with singleton gestation\n* Has an established OBGY at Froedtert \\& the Medical College of Wisconsin (F\\&MCW) Health System\n\nExclusion Criteria:\n\n* Planning to deliver outside of F\\&MCW Health System\n* Receiving support beyond routing prenatal care, such as group prenatal care or has their own doula\n* Inability or unwillingness to provide informed consent","FEMALE","18 Years","65 Years",{"count":76,"type":77},412,"ESTIMATED","INTERVENTIONAL",[80],"NA","The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The study will have three phases: Phase 1 is the qualitative phase of conducting focus groups with Black\u002FAfrican American (AA) birthing people and with medical and community healthcare providers to elicit feedback on how best to integrate community-based doulas and obstetricians into one united model of prenatal care to promote trust and improved maternal health outcomes. Phase 2 tests the effectiveness of the newly developed model on healthcare engagement, trust, and adverse maternal outcomes using randomized control trial of 412 Black\u002FAA pregnant participants. Phase 3 is dissemination of BUNDLE findings in scholarly and community-based forums, including with healthcare leaders and policy makers in Wisconsin, advocating for doula coverage and health system sustainability of the integrated model.",[83],"Pregnancy Related","2026-07-16",{"date":86,"type":87},"2026-07-20","ACTUAL",{"date":89,"type":87},"2025-01-02",{"date":91,"type":77},"2030-06-30",{"name":5,"class":6},1]