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

NCT05791786 | Recruiting

• 1 other identifier: HSC-MS-21-1004
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

To establish a clinical registry of suspected cases of AFE. The existing registry will be migrated to a new platform,

Conditions

Amniotic Fluid Embolism

Outcome Measures

Primary Outcomes (3)

• 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.

  1 year

• 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

  2 weeks

• 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

  3 weeks

Study Arms (1)

AFE

participants of the AFE registry and biorepository include affected individuals diagnosed with AFE 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

Other: Patient

Interventions

Patient OTHER

affected individuals diagnosed with AFE

AFE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant and postpartum women, survivors, offspring, and relatives of patients with suspected AFE through enrollment or chart review.

You may qualify if:

• 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:

You may not qualify if:

• The inability of an individual to provide a signed and dated informed consent form or those who do not wish to participate.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Amniotic Fluid Embolism (AFE) Foundation: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal blood, umbilical cord blood, and neonatal samples:

MeSH Terms

Conditions

Embolism, Amniotic Fluid

Condition Hierarchy (Ancestors)

Pregnancy Complications, Cardiovascular; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiovascular Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Irene Stafford, MD

  UT Health Science Center Health Science Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miranda Klassen

CONTACT

760-444-5505; miranda@afesupport.org

Irene Stafford, MD

CONTACT

713-500-6412; irene.stafford@uth.tmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: July 5, 2022
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)