[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500094":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":33,"responsibleParty":53,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":9,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":10,"maxAge":10,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":10,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AFE",null,"participants of the AFE registry and biorepository include affected individuals diagnosed with AFE\n\nAll subjects or their next of kin must be able to provide a signed and dated informed consent form.\n\nIn the case of lethal AFE, the surviving family member or next of kin must be able to provide a signed and dated informed consent form with an accompanying death certificate and proof of legal kinship",[13],"Other: Patient",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Patient","affected individuals diagnosed with AFE",[9],[20],{"name":21,"affiliation":22,"role":23},"Irene Stafford, MD","UT Health Science Center Health Science Center","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Miranda Klassen","CONTACT","760-444-5505","miranda@afesupport.org",{"name":21,"role":27,"phone":31,"phoneExt":10,"email":32},"713-500-6412","irene.stafford@uth.tmc.edu",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The University of Texas Health Science Center at Houston","RECRUITING","Houston","Texas","77030","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-95.36327,29.76328,{"lat":46,"lon":45},[49],{"name":50,"role":27,"phone":51,"phoneExt":10,"email":52},"Sunbola Ashimi, PhD","713-500-6410","sunbola.s.ashimi@uth.tmc.edu",{"type":23,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Irene Stafford","Associate Professor",[57],{"name":58,"class":59},"Amniotic Fluid Embolism (AFE) Foundation","UNKNOWN","100500094","the-establishment-of-a-registry-and-a-biorepository-of-patients-with-suspected-amniotic-fluid-embolism-afe-100500094",false,"NCT05791786","The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE)","Inclusion Criteria for participants of the AFE registry and biorepository include affected individuals diagnosed with AFE (see below).\n\n* All subjects or their next of kin must be able to provide a signed and dated informed consent form.\n* In the case of lethal AFE, the surviving family member or next of kin must be able to provide a signed and dated informed consent form with an accompanying death certificate and proof of legal kinship.\n* Participants are expected to be willing to permit collection of data about their affected pregnancy, previous and future pregnancies, and their current and future health conditions.\n* Providing biological samples is not required for enrollment.\n* Any maternal death in the Hermann Hospital System suspected of having an AFE within 24 hours of childbirth between 1\u002F2012 and 1\u002F2023 will also be included for data analysis and biospecimen studies\n* Medical records will be abstracted into a comprehensive case report form and then reviewed by a team of three experts with consensus to determine case classification of three categories, according to criteria previously reported and based on data generated from the previously existing registry:\n\n  (1) Classic AFE is defined by the following indicators:\n* Acute hypotension or cardiac arrest,\n* Acute hypoxia, defined as dyspnea, cyanosis, or respiratory arrest,\n* Coagulopathy, defined as laboratory evidence of intravascular consumption or fibrinolysis or severe clinical hemorrhage in the absence of other explanations,\n* Onset of the above during labor, cesarean section, or dilation and evacuation or within 30 minutes post-partum, and\n* Absence of any other significant confounding condition or potential explanation for the signs and symptoms observed.\n\n  (2) Not AFE:\n* Anything that clinically appears to be a likely result of another pathophysiology, e.g., delayed treatment of postpartum hemorrhage from uterine atony.\n\n  (3) Atypical AFE:\n* Subjective determination by the chart reviewer that lies between \"classic\" and \"not,\" e.g., the patient presents some of the registry criteria and no other explanation.\n\n  (4) Indeterminate: There is not sufficient information to classify in 1-3 above.\n\nThe classification of AFE is for research purposes only.\n\nExclusion Criteria:\n\n* The inability of an individual to provide a signed and dated informed consent form or those who do not wish to participate.","ALL",{"count":68,"type":69},400,"ESTIMATED","2 Weeks","OBSERVATIONAL","To establish a clinical registry of suspected cases of AFE. The existing registry will be migrated to a new platform,",[74],"Amniotic Fluid Embolism","2026-05-04",{"date":77,"type":78},"2026-05-08","ACTUAL",{"date":80,"type":78},"2022-07-05",{"date":82,"type":69},"2031-12-31",{"name":5,"class":6},1]