🔎 Trials Near Me

Home › NCT05791786

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

Sponsor: The University of Texas Health Science Center, Houston · Participants: 400 · Started: Jul 5, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05791786

Locations in the U.S.

TexasThe 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.