New registry aims to unlock secrets of rare pregnancy complication
NCT ID NCT05791786
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is creating a registry and biorepository for people who have had a suspected amniotic fluid embolism (AFE), a rare and serious pregnancy complication. Researchers will collect medical information and biological samples from up to 400 participants, including mothers, their children, and family members. The goal is to better understand AFE and improve future care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Pregnant and postpartum women, survivors, offspring, and relatives of patients with suspected AFE through enrollment or chart review.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas Health Science Center at Houston
RECRUITINGHouston, Texas, 77030, United States