AFE Patient Registry

Help Prevent Amniotic Fluid Embolism

A patient registry is a place where medical information, family history and other related medical and non-medical information from patients is collected and stored for medical research. This information will be helpful in better understanding individual cases of AFE, commonalities, treatments, as well as learn the long-term health of those who have survived an AFE.

Amniotic fluid embolism (AFE) is a rare occurrence making it difficult to study. The AFE Foundation and Baylor College of Medicine in Houston, Texas have formed the Amniotic Fluid Embolism Registry, a database of AFE cases to allow researchers the ability to advance their knowledge of the condition and develop a means for prevention and treatment.

Surviving patients or family members of a loved one lost to an amniotic fluid embolism are encouraged to submit their case. Complete the information below to begin the process. A research coordinator from the AFE Foundation will respond in 7-10 business days to provide you with more information and the necessary paperwork to enroll.

If you are a health care provider, please submit the information and omit the patient’s name. We will work with you to consent the patient or their family member.

Submit a Case

Frequently Asked Questions

What information are you gathering?

We are collecting data from women who were medically diagnosed or presumed to have suffered an amniotic fluid embolism. The types of data collected will include any or all of the following:

  1. Prenatal records
  2. Medical records from the hospital where the AFE birth took place
  3. Death Certificates, Autopsy or Medical Examiner Records
  4. Medical history questionnaire and any additional documentation for previous or subsequent pregnancies.

What if my records don’t give a diagnosis of AFE?

Since AFE is a diagnosis of exclusion, many times patients or their family members are told the complication is an AFE however, the medical records do not state an AFE diagnosis. Terms often used are “presumed” or “possible”. You may still submit your enrollment forms.

Can I enroll a mother who died or is disabled as a result of an amniotic fluid embolism?

Yes. You will need to provide adequate proof that you have the legal authority to submit enrollment paperwork. Our research coordinator will work with you to determine the proper documentation needed.

Can I participate if I live outside the United States?

Yes. The Registry is available to participants anywhere in the world. However, since each facility, state, and country have their own regulatory requirements, further documentation may be needed for those outside of the United States.

Can I participate if I am under the age of 18?

Yes.  A parent or guardian will need to review the consent form with you.  Both you and your parent or guardian will need to agree for you to participate. 

Who do I call if I have questions about the Registry?

Please contact the Research Coordinator at Baylor College of Medicine, Elizabeth Soriano, at 832-826-7451 or email at aferegistry@bcm.edu or Miranda Klassen at 760-444-5505 or miranda@afesupport.org.

Who is paying for the Registry?

The sponsor of the Registry is the AFE Foundation.  There is no cost to be a participant of the Registry.  All costs are paid for by the Foundation.  As a 501(c)(3) non-profit organization, the Foundation’s mission is made possible through individual and corporate donations.  If you would like to support this and/or other initiatives, please consider a gift to the Foundation in honor or memory of a loved one or as a general donation. Please contact Miranda Klassen, Executive Director to discuss corporate or major gift support.

Will you collect any blood or other biological samples for research (such as genetic testing)?

Sometimes a registry may also be linked to a biobank: a place that stores tissue, blood or other samples from patients.  The AFE Patient Registry has developed a biobank where some participants may be invited to provide a saliva sample from which we will extract DNA.  When first enrolling in the registry there will be a section on the consent form where you can give your permission for us to contact you about donating a biological specimen for research.  If you are invited to participate in the biobank, you will need to agree to a separate consent form before enrolling in the biobank.

Will anyone else know my name?

Your personal information such as your name, address, or other information that identifies you or your family will be labeled with a code number, encrypted, stored in a secure place and protected with a password. Only authorized investigators will have access to the code and be able to identify you, if needed.Your identifiable information will not be shared with anyone outside the Registry. Approved scientists, researchers, and clinicians, will be given only the de-identified information and may search the de-identified data for patients for their studies. We call this information “de-identified” because all personal identifiers have been removed.

All other information (such as hard copies of records) will be stored in locked files and destroyed in accordance to the standards established by the HIPAA Privacy Act. To review the entire HIPAA Privacy Act, and for information about how it applies to patients, see the Office for Civil Rights website: http://www.hhs.gov/ocr/hipaa.

Can insurance companies access my medical information and/or my participation in this study?

Insurance companies are not permitted access to research records, and participants do not have to tell their health insurance companies that they have participated in a research project.  Research is different from clinical care.  Research records are not a part of a person’s medical record.

The Genetic Information Nondiscrimination Act (GINA) of 2008 is intended to prohibit the improper use of genetic information. GINA provides comprehensive protection to individuals so that they may avail themselves of genetic diagnostic tests for the advancement of their individualized medical care without the threat of discrimination from insurance companies based on their personal genetic makeup. To review the entire Genetic Information Nondiscrimination Act of 2008 and other helpful information regarding GINA, go to http://www.genome.gov/11510239.

What else will be expected from me?

After enrollment in the registry, and with your permission, you can expect the following:

  1. To be contacted by email or phone at least once a year to update your information.
  2. Answer new questions as we or outside researchers have new ideas to explore.
  3. Your information will be combined with others’ and shared with researchers, but your identity will not be shared.  Your privacy remains our top priority.
  4. You may be contacted about donating a sample of blood, tissue, or other biological specimen.  (If you decide to donate a sample, you will need to provide separate consent)

Why do you need to look at my medical records?

By reviewing your medical records pertaining to your pregnancy and birth we are able to retrieve vital information on the specifics of your care such as heart rate, medications, interventions, timing of activities, etc. This is very important to our research studies.  The Registry will remove your personal identifying information (name, date of birth, etc.) from your medical records and replace it with a code before your records are ever shared with other researchers, databases, or registries.

What are the risks?

There is minimal risk in being a Participant of the Registry.  The Registry questionnaire includes questions that can be sensitive, and may elicit an emotional response, or something that you may feel uncomfortable answering.   You do not have to share any information you do not want to.

What if I decide I do not want to participate after enrolling?

Should you change your mind and wish to withdraw your data from The AFE Patient Registry, you will be free to do so without providing any explanation.  However, information accessed prior to the request for removal cannot be retrieved from researchers that have already accessed it.  You may withdraw your participation by writing an email to aferegistry@bcm.edu or by writing a letter to:

BAYLOR COLLEGE OF MEDICINE
OB/GYN Department – Research
Attn: Elvira Munoz
6651 Main St., Ste. 1020
Houston, TX  77030

How can I provide the Registry with an update on my/my child's health or a new pregnancy?

The Registry is most valuable when your information is kept up-to-date.  Please email any changes to your records to aferegistry@bcm.edu.

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