[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607938":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":33,"responsibleParty":51,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Columbia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Trauma Informed Obstetric Care (TIOC)","EXPERIMENTAL","Women randomized to the trauma informed obstetric care (TIOC) intervention will be scheduled for all their prenatal appointments with obstetricians trained in the TIOC model. Additionally, the midwife on duty in the delivery ward will ensure that all items on a checklist of trauma-sensitive birth practices are followed during that participant's labor and delivery",[13],"Behavioral: Trauma Informed Obstetric Care (TIOC)",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment as usual (TAU)","NO_INTERVENTION","Participants randomized to TAU will receive usual prenatal care, which includes a referral to psychological services when deemed necessary by the prenatal care provider. These participants' prenatal visits will not be scheduled with providers who have received TIOC training.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","TIOC providers will receive a training that was developed for this study. Elements of trauma-informed care described in the literature -combined with the experience of the study team, with deep expertise in trauma-informed obstetric care, were used to create three training modules, each of which includes didactics and role-plays to help participants practice and embody skills they learn. The three modules are:\n\n1. Effects of trauma on physiological and psychological process relevant to pregnancy and childbirth.\n2. Body language and verbal language for safety, respect, and patient agency\n3. Recognizing and responding to distress and dissociation",[9],[25],{"name":26,"affiliation":5,"role":27},"Pamela Scorza, ScD","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","646-246-1092","pls2122@cumc.columbia.edu",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hospital Materno Infantil Ramon Sardá","RECRUITING","Buenos Aires","Buenos Aires F.D.","C1246ABQ","Argentina","AR",{"type":43,"coordinates":44},"Point",[45,46],-58.37723,-34.61315,{"lat":46,"lon":45},[49],{"name":50,"role":27,"phone":18,"phoneExt":18,"email":18},"Sergio Casini",{"type":27,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Pamela Scorza","Assistant Professor of Women's Mental Health in Psychiatry",[55],{"name":56,"class":57},"Hospital Materno Infantil Ramón Sardá","NETWORK","100607938","trauma-informed-obstetric-care-for-perinatal-health-a-pilot-study-100607938",false,"NCT07195058","Trauma-informed Obstetric Care for Perinatal Health: a Pilot Study","Trauma-informed Obstetric Care for Perinatal Health in Women With Histories of Childhood Abuse: a Pilot Randomized Clinical Trial","Inclusion Criteria:\n\n* Women who are \\\u003C19 weeks pregnant\n* Nulliparous (no previous live births)\n* 18 or more years of age\n* Carrying a single fetus\n* Can speak Spanish\n\nExclusion Criteria:\n\n* Any current psychiatric diagnosis or treatment\n* Medical complications (hypertension, cardiac disease, diabetes, chronic disease, autoimmune disease) before pregnancy",true,"FEMALE","18 Years","45 Years",{"count":70,"type":71},60,"ESTIMATED","INTERVENTIONAL",[74],"NA","The study will test trauma-informed obstetric care training and supervision for obstetric clinicians in relation to prenatal mental health and attachment formation (early predictors of child development) in women presenting for prenatal care in a public hospital in Buenos Aires, Argentina.",[77,78,79],"Mother to Child Transmission","Breast Feeding","Trauma",[81,82,83,84,85,86,87,88],"Adverse childhood experiences (ACE)","Edinburgh Postnatal Depression Scale (EPDS)","Perceived Stress Scale (PSS)","Maternal antenatal attachment scale (MAAS)","Social Support Questionnaire (SSQ)","Prenatal Distress Questionnaire (NuPDQ)","Iowa Infant Feeding scale (IIFAS)","Trauma Informed Care","2025-09-19",{"date":91,"type":92},"2025-09-26","ACTUAL",{"date":94,"type":92},"2025-05-23",{"date":96,"type":71},"2027-01",{"name":5,"class":6},1]