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The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE)
RecruitingObservational study
Who can join
All ages · All sexes
Full eligibility criteria
Inclusion Criteria for participants of the AFE registry and biorepository include affected individuals diagnosed with AFE (see below). * All subjects or their next of kin must be able to provide a signed and dated informed consent form. * 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. * 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. * Providing biological samples is not required for enrollment. * Any maternal death in the Hermann Hospital System suspected of having an AFE within 24 hours of childbirth between 1/2012 and 1/2023 will also be included for data analysis and biospecimen studies * 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: (1) Classic AFE is defined by the following indicators: * Acute hypotension or cardiac arrest, * Acute hypoxia, defined as dyspnea, cyanosis, or respiratory arrest, * Coagulopathy, defined as laboratory evidence of intravascular consumption or fibrinolysis or severe clinical hemorrhage in the absence of other explanations, * Onset of the above during labor, cesarean section, or dilation and evacuation or within 30 minutes post-partum, and * Absence of any other significant confounding condition or potential explanation for the signs and symptoms observed. (2) Not AFE: * Anything that clinically appears to be a likely result of another pathophysiology, e.g., delayed treatment of postpartum hemorrhage from uterine atony. (3) Atypical AFE: * 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. (4) Indeterminate: There is not sufficient information to classify in 1-3 above. The classification of AFE is for research purposes only. Exclusion Criteria: * The inability of an individual to provide a signed and dated informed consent form or those who do not wish to participate.
About the study
To establish a clinical registry of suspected cases of AFE. The existing registry will be migrated to a new platform,
What is being tested
- Patient (other)
Sponsor: The University of Texas Health Science Center, Houston · Participants: 400 · Started: Jul 5, 2022
Contact the study team
- Miranda Klassen · Phone: 760-444-5505
- Irene Stafford, MD · Phone: 713-500-6412
Official record on ClinicalTrials.gov — NCT05791786
Locations in the U.S.
| Texas | The University of Texas Health Science Center at Houston, Houston |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.