Amniotic Fluid EmbolismAFENCT05791786
The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE)
An observational study of Amniotic Fluid Embolism, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
To establish a clinical registry of suspected cases of AFE. The existing registry will be migrated to a new platform, Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amniotic Fluid Embolism
- What is being tested?
- Patient
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 31 Dec 2031
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant and postpartum women, survivors, offspring, and relatives of patients with suspected AFE through enrollment or chart review.
Who may be able to join
None listed.
Who cannot join
- The inability of an individual to provide a signed and dated informed consent form or those who do not wish to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sunbola Ashimi, PhD, 713-500-6410, sunbola.s.ashimi@uth.tmc.edu
About this study
To establish a clinical registry of suspected cases of AFE. The existing registry will be migrated to a new platform,
Read the detailed description
The registry and the biorepository have prospective and retrospective components.
The prospective component of the registry and the biorepository focuses on the collection of demographic, clinical, and biological material of patients prospectively identified as having the AFE syndrome, including the collection of future samples from survivors and related individuals. Typically, healthcare providers, family members of an affected patient, or patients themselves contact the AFE Foundation. The AFE Foundation provides information about the natural history of the syndrome and its outcomes and invites patients to participate in the registry and biorepository. The AFE Foundation obtains informed consent from patients or next of kin for enrollment in this observational study. There is no randomization or placebo group for this registry as it is exclusively an observational study. If maternal specimens are available pre- and post-event during the hospital admission for delivery, these samples will also be collected from each patient. The only group assignment will be the subjects with a diagnosis of AFE and the subjects' family members including the partner(s) and child (children).
The retrospective component of the registry consists of obtaining clinical information and biological material from patients who have been previously affected by the AFE syndrome. This objective includes obtaining medical records, patient-provided information, pathology reports, autopsy reports, and tissue blocks. Biological samples can also be obtained from survivors and relatives to determine whether there are biomarkers in previously affected patients or whether biomarkers can be elicited from the stimulation of peripheral blood cells. In addition to collecting data and specimens from the patients that are consented and enrolled through the registry, a query of all maternal deaths within 24 hours of birth between 1/2012 to 1/2023 will be performed at the Hermann Hospital system to identify if any of these deaths occurred secondary to AFE. The investigators intend to perform a detailed chart review and collect otherwise discarded tissue if available from the respective hospital to perform special immunohistochemistry staining among women who underwent autopsy.
- Conditions
- Amniotic Fluid Embolism
- Being tested
- Patient
- Medical subject headings
- Embolism, Amniotic Fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatientOther
affected individuals diagnosed with AFE
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start5 Jul 2022
- Primary completion1 Oct 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amniotic Fluid EmbolismStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Amniotic Fluid Embolism (AFE) Foundation
- Responsible party
- Principal investigator, Irene Stafford, The University of Texas Health Science Center, Houston
- Investigators
- Irene Stafford, MD, Principal investigator, UT Health Science Center Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791786
- Sponsor's protocol ID
- HSC-MS-21-1004
- Acronym
- AFE
- Status last verified
- May 2026
- First submitted
- 17 Mar 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE)
- ClinicalTrials.gov ID
- NCT05791786
- Acronym / sponsor ID
- AFE / HSC-MS-21-1004
- Conditions
- Amniotic Fluid Embolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Amniotic Fluid Embolism (AFE) Foundation
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 1 Oct 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish a clinical registry of suspected cases of AFE. The existing registry will be migrated to a new platform,
Detailed description
The registry and the biorepository have prospective and retrospective components.
The prospective component of the registry and the biorepository focuses on the collection of demographic, clinical, and biological material of patients prospectively identified as having the AFE syndrome, including the collection of future samples from survivors and related individuals. Typically, healthcare providers, family members of an affected patient, or patients themselves contact the AFE Foundation. The AFE Foundation provides information about the natural history of the syndrome and its outcomes and invites patients to participate in the registry and biorepository. The AFE Foundation obtains informed consent from patients or next of kin for enrollment in this observational study. There is no randomization or placebo group for this registry as it is exclusively an observational study. If maternal specimens are available pre- and post-event during the hospital admission for delivery, these samples will also be collected from each patient. The only group assignment will be the subjects with a diagnosis of AFE and the subjects' family members including the partner(s) and child (children).
The retrospective component of the registry consists of obtaining clinical information and biological material from patients who have been previously affected by the AFE syndrome. This objective includes obtaining medical records, patient-provided information, pathology reports, autopsy reports, and tissue blocks. Biological samples can also be obtained from survivors and relatives to determine whether there are biomarkers in previously affected patients or whether biomarkers can be elicited from the stimulation of peripheral blood cells. In addition to collecting data and specimens from the patients that are consented and enrolled through the registry, a query of all maternal deaths within 24 hours of birth between 1/2012 to 1/2023 will be performed at the Hermann Hospital system to identify if any of these deaths occurred secondary to AFE. The investigators intend to perform a detailed chart review and collect otherwise discarded tissue if available from the respective hospital to perform special immunohistochemistry staining among women who underwent autopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AFE | – | Other: Patientparticipants 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant and postpartum women, survivors, offspring, and relatives of patients with suspected AFE through enrollment or chart review.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- The inability of an individual to provide a signed and dated informed consent form or those who do not wish to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patientaffected individuals diagnosed with AFE | Other | AFE |
Primary outcome
To establish a clinical registry of suspected cases of AFE
Time frame: 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.
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: 2 weeks
biological materials would be sought from mothers, their children, and other related individuals
To obtain clinical data and biological specimens from individuals previously enrolled in the registry
Time frame: 3 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irene Stafford, MD principal investigator
UT Health Science Center Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amniotic Fluid Embolism, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miranda Klassen (760-444-5505, miranda@afesupport.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish a clinical registry of suspected cases of AFE (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.