The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Emb… (NCT05791786) | Clinical Trial Compass
RecruitingNot Applicable
The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE)
United States400 participantsStarted 2022-07-05
Plain-language summary
To establish a clinical registry of suspected cases of AFE. The existing registry will be migrated to a new platform,
Who can participate
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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 …
What they're measuring
1
To establish a clinical registry of suspected cases of AFE
Timeframe: 1 year
2
The existing registry will be migrated to a new platform, thus to enhance and strengthen the content and the quality of the data obtained.
Timeframe: 2 weeks
3
To obtain clinical data and biological specimens from individuals previously enrolled in the registry
Timeframe: 3 weeks
Trial details
NCT IDNCT05791786
SponsorThe University of Texas Health Science Center, Houston