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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Patient

    Other intervention

    affected individuals diagnosed with AFE

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: AFE1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

biological materials would be sought from mothers, their children, and other related individuals

Time frame
2 weeks
3

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

Time frame
3 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Amniotic Fluid Embolism (AFE) Foundation

Collaborator