Registry and biorepository for patients with suspected Amniotic Fluid Embolism

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

This study is setting up a registry to collect information from patients suspected of having Amniotic Fluid Embolism to better understand the condition.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05791786 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a clinical registry and biorepository for patients suspected of having Amniotic Fluid Embolism (AFE). It includes both prospective and retrospective components, collecting demographic, clinical, and biological data from affected individuals and their families. The registry will gather information from healthcare providers and family members, with informed consent obtained for participation. The study does not involve randomization or a placebo group, focusing solely on observational data collection.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with AFE and their family members who can provide informed consent.

Not a fit: Patients who have not been diagnosed with AFE or whose family members are unable to provide consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this initiative could enhance understanding of AFE and improve outcomes for affected patients.

How similar studies have performed: While this approach is observational and builds on existing knowledge, similar registries have shown promise in enhancing understanding of rare conditions.

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.

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Irene Stafford, MD — UT Health Science Center Health Science Center
• Study coordinator: Miranda Klassen

Conditions: Amniotic Fluid Embolism