Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05791786

Conditions

Amniotic Fluid Embolism

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Patient

Study Details

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

Study ID

NCT05791786

Start date

Jul 5, 2022

Status verified date

May, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Oct 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Patient

affected individuals diagnosed with AFE

Primary outcome measure

  • 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. [ Time Frame: 2 weeks ]
  • To obtain clinical data and biological specimens from individuals previously enrolled in the registry [ Time Frame: 3 weeks ]

Central Contacts and Locations

Central contacts

Miranda Klassen

760-444-5505miranda@afesupport.org

Irene Stafford, MD

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Sunbola Ashimi, PhD

713-500-6410sunbola.s.ashimi@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-05-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.