[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100348679":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":83,"collaborators":85,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":23,"eligibilityCriteria":95,"healthyVolunteers":92,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":23,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":41,"whyStopped":23,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Pregnant women and their partners","For the qualitative arm of this mixed method study, using an exploratory sequential design, investigators will enroll \\~ 30 adult pregnant women admitted estimated 22 0\u002F7-25 6\u002F7 weeks' estimated gestation and their partners to participate in a post-counseling semi-structured interview to explore preferred language and approaches, and better inform questionnaire development. Sample size will be up to 30 families, or until thematic saturation is achieved (total up to 60 if all partners agree to participate).\n\nFor the quantitative arm of this study, investigators will enroll \\~100 adult pregnant women admitted between estimated 22 0\u002F7-25 6\u002F7 weeks' estimated gestation and their partners (up to total \\~200 if all partners present and agree to participate).",[12],"Behavioral: Educational intervention",{"label":14,"type":6,"description":15,"interventionNames":16},"Counseling MFM and Neonatology providers","Investigators will enroll \\~100 counseling Maternal-Fetal Medicine (MFM) specialists and 100 counseling Neonatologists (total \\~200 providers), who provided counseling to the enrolled pregnant women between 22 0\u002F7-25 6\u002F7 weeks' estimated gestation for anticipated extremely preterm delivery. This assumes 1 counseling provider from MFM and 1 from Neonatology per pregnant woman, although there could be more if a consult is performed by both an attending physician and a training fellow or practitioner, or less, if a counseling provider declines to participate in the study. There will be anticipated repetition of counseling providers, accounted for in the statistical analysis. Providers will be asked to complete educational interventions to improve counseling at extreme prematurity.",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"BEHAVIORAL","Educational intervention","Investigators will first determine preferred language and approaches by families, then redefine current training for prenatal counseling at extreme prematurity by developing and implementing two novel, interdisciplinary simulation-based educational programs for MFM and Neonatology (a workshop and an online module), focusing on eliciting values and building partnerships through advanced communication and relational skills, to improve counseling practices and outcomes",[14,9],null,[25],{"name":26,"affiliation":5,"role":27},"Christy Cummings","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},"Christy L Cummings, MD","CONTACT","617-355-2539","christy.cummings@childrens.harvard.edu",{"name":35,"role":31,"phone":36,"phoneExt":23,"email":37},"Vanessa J Young, RN, BA","617-355-8330","vanessa.young@childrens.harvard.edu",[39,58,69],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Boston Children's Hosptial","RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-71.05977,42.35843,{"lat":51,"lon":50},[54],{"name":55,"role":31,"phone":56,"phoneExt":23,"email":57},"Christy Cummings, MD","6173552539","Christy.Cummings@childrens.harvard.edu",{"facility":59,"status":41,"city":42,"state":43,"zip":60,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Beth Israel Deaconess Medical Center","02215",{"type":48,"coordinates":62},[50,51],{"lat":51,"lon":50},[65],{"name":66,"role":31,"phone":67,"phoneExt":23,"email":68},"John Zupancic, MD","6176673276","jzupanci@bidmc.harvard.edu",{"facility":70,"status":41,"city":71,"state":43,"zip":72,"country":45,"countryCode":46,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"South Shore Hospital","Weymouth","02190",{"type":48,"coordinates":74},[75,76],-70.93977,42.22093,{"lat":76,"lon":75},[79],{"name":80,"role":31,"phone":81,"phoneExt":23,"email":82},"Bonnie Arzuaga, MD","6173554647","Bonnie.Arzuaga@childrens.harvard.edu",{"type":27,"investigatorFullName":26,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Assistant Professor of Pediatrics",[86,87,89],{"name":59,"class":6},{"name":88,"class":6},"Brigham and Women's Hospital",{"name":70,"class":6},"100348679","optimizing-family-counseling-for-anticipated-extremely-preterm-delivery-100348679",false,"NCT03819933","Optimizing Family Counseling for Anticipated Extremely Preterm Delivery","1. Pregnant women and their partners\n\n   Inclusion Criteria:\n   * English-proficient adult pregnant woman admitted between 22 0\u002F7-25 6\u002F7 weeks' estimated gestation for anticipated extremely preterm delivery and her adult partner (if available) for whom an antenatal neonatal intensive care unit (NICU) consultation was requested and performed\n\n   Exclusion Criteria:\n   * Non-English proficient\n   * Fetal congenital malformation(s)\n   * \\\u003C18y old\n   * \\\u003C22 0\u002F7 or \\> 25 6\u002F7 weeks' estimated gestation\n   * Repeat consultation\n2. Counseling MFM and Neonatology providers\n\nInclusion Criteria:\n\n* Practicing MFM or Neonatology provider (attending, fellow, resident, practitioner or RN) from the 3 participating sites: Brigham \\& Women's Hospital (BWH), Beth Israel Deaconess Medical Center (BIDMC), South Shore Hospital (SSH)\n\nExclusion Criteria:\n\n* None","ALL","18 Years","99 Years",{"count":100,"type":101},460,"ESTIMATED","INTERVENTIONAL",[104],"NA","Antenatal family counseling for anticipated extremely preterm deliveries remains ethically and practically challenging for maternal-fetal medicine specialists and neonatologists alike. The overall goal of this project is to improve antenatal counseling and counseling outcomes for families facing anticipated extremely preterm delivery through innovative, interdisciplinary simulation-based education for maternal fetal medicine specialists and neonatologists, using language preferred by families, and focusing on eliciting values and building partnerships through advanced communication and relational skills.",[107,108],"Preterm Pregnancy","Premature Birth",[110,111],"Counseling","Extreme Prematurity","2025-12-08",{"date":114,"type":115},"2025-12-16","ACTUAL",{"date":117,"type":115},"2019-09-17",{"date":119,"type":101},"2027-02-28",{"name":5,"class":6},3]