[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07684521":3,"trial-entities:NCT07684521":90,"trial-summary:NCT07684521":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":63,"locations":66,"central_contacts":82,"overall_officials":84,"references":88,"see_also_links":89},"NCT07684521","STUDY00004928","Debriefing Consult for Psychiatric Symptoms After Severe Maternal Morbidity","Does a Debriefing Intervention After a Delivery Complicated by Severe Maternal Morbidity Reduce Post-traumatic, Depression, or Anxiety Symptoms? A Randomized Controlled Trial","NOT_YET_RECRUITING","2030-07","2026-06","2026-07-06","2026-07-01","Cedars-Sinai Medical Center","OTHER",false,"The primary objective of this study is to determine if a maternal fetal medicine (MFM) debriefing consult six to eight weeks postpartum reduces self-reported post-traumatic stress, depression, and anxiety symptoms following a delivery complicated by severe maternal morbidity (SMM). Individuals with a delivery complicated an intensive care unit (ICU) admission and\u002For blood product transfusion \\>4 units will be included in this study. Participants will be randomized to an intervention or control group; all participants will complete patient questionnaires that screen for post-traumatic stress disorder, depression, and anxiety. Those in the control group will receive a virtual MFM debriefing consult at six weeks postpartum and those in the intervention group will have the option for a consult at twelve weeks postpartum, after the completion of the questionnaires.",null,[19,20,21,22],"PTSD (Childbirth-Related)","Severe Maternal Morbidity","Depression - Major Depressive Disorder","Anxiety",[24,25,26,27],"severe materal morbidity","PTSD","anxiety","depression","INTERVENTIONAL","SUPPORTIVE_CARE",[31],"NA",{"count":33,"type":34},52,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","Virtual maternal fetal medicine debriefing consult","The intervention is virtual debriefing consult with a maternal fetal medicine subspecialist. This intervention involves review of the patient's hospital course and delivery experience, and recommendations for future pregnancies if desired.",[41],"Intervention group",[43,47,50],{"measure":44,"description":45,"timeFrame":46},"Depression symptoms","Edinburgh Postnatal Depression Scale (EPDS) score","From 6 to 12 weeks postpartum",{"measure":48,"description":49,"timeFrame":46},"PTSD symptoms","Impact of Event Scale - Revised (IES-R) score",{"measure":51,"description":52,"timeFrame":46},"Anxiety symptoms","Generalized Anxiety Disorder 7-item (GAD-7) score",[],"FEMALE","18 Years",{"inclusion":57,"exclusion":58,"raw_text":62},[],[59,60,61],"Age \\\u003C18 years","Non-English speakers","Any records flagged \"break the glass\" or \"research opt out\"","Inclusion Criteria:\n\n\\- Individuals with a delivery complicated by severe maternal morbidity, defined as intensive care unit (ICU) admission and\u002For blood product transfusion \\>4 units\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Non-English speakers\n* Any records flagged \"break the glass\" or \"research opt out\"",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":79},"Cedars Sinai Medical Center","Los Angeles","California","90048","United States",[74],{"name":75,"role":76,"phone":77,"email":78},"Sarena Hayer, MD, MA, MSc","CONTACT","323-866-8107","sarena.hayer@cshs.org",{"lat":80,"lon":81},34.05223,-118.24368,[83],{"name":75,"role":76,"phone":77,"email":78},[85],{"name":86,"affiliation":13,"role":87},"Sarah Kilpatrick, MD, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":91,"biomarkers":94},[22,92,20,93],"Post-Traumatic Stress Disorder","Unipolar Depression",[],{"nct_id":4,"found":96,"summary":97,"prompt_version":106},true,{"design":98,"status":99,"heading":6,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an interventional study planning to enroll 52 participants. Participants will be randomly assigned to either receive the virtual debriefing consult or be in a control group.","completed","This study is looking at whether a virtual debriefing consult with a maternal fetal medicine (MFM) specialist can help reduce symptoms of post-traumatic stress disorder (PTSD), depression, and anxiety in women who experienced severe complications during childbirth. Severe complications are defined as needing intensive care unit (ICU) admission or receiving more than 4 units of blood. The consult would involve reviewing your hospital stay and delivery, and offering advice for future pregnancies. The study aims to see if this consult, given 6 to 8 weeks after delivery, can improve these symptoms. You can join if you are a woman aged 18 or older who experienced these childbirth complications. The current recruitment status is unclear.","Symptoms of depression, PTSD, and anxiety will be measured between 6 and 12 weeks postpartum.",114,"All participants will complete questionnaires to screen for post-traumatic stress disorder, depression, and anxiety.","Not stated in the trial record.",[],"v2"]