About this trial
To establish a clinical registry of suspected cases of AFE. The existing registry will be migrated to a new platform,
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
The inability of an individual to provide a signed and dated informed consent form or those who do not wish to participate.
Trial population
Pregnant and postpartum women, survivors, offspring, and relatives of patients with suspected AFE through enrollment or chart review.
Trial design
Cohort
Prospective
Treatments tested in this trial
Patient
Other interventionaffected individuals diagnosed with AFE
Treatment groups
Trial outcomes
Primary outcomes
To establish a clinical registry of suspected cases of AFE
The existing registry will be migrated to a new platform, thus to enhance and strengthen the content and the quality of the data obtained.
The existing registry will be migrated to a new platform, thus to enhance and strengthen the content and the quality of the data obtained.
biological materials would be sought from mothers, their children, and other related individuals
To obtain clinical data and biological specimens from individuals previously enrolled in the registry
This objective includes the review of autopsy material and pathology reports, as well as the collection of biological material of survivors and members of the family, to determine whether there is a susceptibility to the AFE syndrome
Sponsors and contacts
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The University of Texas Health Science Center, Houston
Lead sponsor
Amniotic Fluid Embolism (AFE) Foundation
Collaborator