The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE)

Inclusion Criteria18

• 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.