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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Mar 17, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on understanding a serious condition called Amniotic Fluid Embolism (AFE), which can occur during or shortly after childbirth. The researchers aim to create a registry, which is like a database, to collect information about patients who are suspected of having AFE. This registry will be moved to a new platform to improve data collection and analysis. The study is currently recruiting participants, including women diagnosed with AFE and their family members, to help gather important information about their pregnancies and health.

To be eligible for this study, participants or their next of kin need to provide a signed consent form. This is important for including both those with suspected AFE and, in cases of maternal death related to AFE, their surviving family members. Participants can expect to share details about their pregnancies and health, but they are not required to provide biological samples unless they choose to. The information collected will be reviewed by a team of experts to help classify cases of AFE for research purposes. This study aims to enhance our understanding of AFE and ultimately improve care for those affected.

Gender

ALL

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.