Star Legacy Foundation

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Pregnancy Research Project

What is a registry?
A patient registry is a place where medical information, family history and other related information from patients is collected and stored for medical research.   This information will be helpful in better understanding what causes poor pregnancy outcomes and strategies to prevent poor outcomes.

Why are you wanting to study pregnancies?

While most pregnancies end happily, unfortunately, far too many do not.  In some cases the baby has died before birth, only lived a short time after birth or was born with a limiting medical condition.  Research is lacking to learn more about why these things happen and what can potentially be done to prevent them.

How will the Pregnancy Research Project help research?

Enrolling patients who meet the criteria for a specific study may take many years. By collecting a larger amount of information from as many patients as possible, the researchers may finish their enrollment in a matter of days.

Who can participate in The Pregnancy Research Project?

We are collecting data from:

  • Women who had a pregnancy last at least 12 weeks in the last 15 years, regardless of the pregnancy outcome,  AND
  • Women who are currently pregnant at 12 or more gestational weeks

What is considered a poor pregnancy outcome?

Any mother that does not end with a healthy mother and health baby is considered a poor outcome.

What records will you request?

For mothers who have already delivered their baby, records will be requested of the mothers prenatal course as well as hospital and delivery records, laboratory results, and medical imaging.  If the mother delivered a living baby, the newborn hospital records will also be requested.

Can I participate if I live outside the United States?

Yes.  The Pregnancy Research Project is available to participants anywhere in the world as long as the mother can complete the survey in English and the medical record is in English.  We plan to expand the Pregnancy Research Project to non-English speaking mothers and medical records that are not in English in the near future.

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.  You will also need to provide your assent.  Please ask the Pregnancy Research Project staff any questions before agreeing to participate.

Why do you only include records on pregnancies at 12 or more weeks?

We are certainly concerned about all pregnancies, however, this project depends upon comprehensive data.  Most times, pregnancies are not confirmed by obstetrical care providers prior to 12 weeks and as a result medical records on the pregnancy don’t exist or if they do, very little information is available.

Who do I call if I have questions about the Pregnancy Research Project?

Call the Pregnancy Research Project Coordinator at the Star Legacy Foundation at 952-715-7731 or email at research@starlegacyfoundation.org

Who is paying for the Pregnancy Research Project?

The sponsor of the Pregnancy Research Project is the Star Legacy Foundation.  There is no cost to be a participant of the Pregnancy Research Project. 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 Star Legacy Foundation in honor or memory of a loved one, or just as an outright donation.  Please contact us at 952-715-7731 or email research@starlegacyfoundation.org to discuss corporate or major gift support.

Once data is available for researchers, a small fee will be charged for data requests to off-set the data storage and processing for their request.

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

No.  If genetic test results are included in your medical records, they will be recorded.  But no new testing or samples will be collected.

If a researcher would like to do a future study that requires new tests or samples, they may ask us to inform eligible women who are interested.  You are not required to participate in any of these future studies and will not be contacted by the researchers directly without your prior consent.

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, ecnrypted, stored in a secure location and protected with a password.  Only authorized people who work in the Pregnancy Research Project will have access to the code and will be able to identify you, if needed.

Your identifiable information will not be shared with anyone outside the Pregnancy Research Project.  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 the Pregnancy Research Project?

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 part of a person’s medical records.

Is there any compensation for participating?

There is no cost to you to participate and you will not receive compensation for participation.

I don’t have much time.  What exactly is involved?

The entire process should take no more than 1 hour.  First, click “Enroll Now” to enter your information, review, and complete the consent form.  Next complete the medical record authorization so that the Pregnancy Research Project can request your records from your clinic(s) and hospital(s).  Finally complete the maternal survey.

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

  • To be contacted by email or phone once a year by the Pregnancy Research Project to update your information.
  • To be contacted by email or phone if the Pregnancy Research Project becomes aware of another study you may want to consider participating in.

Why do you ask for a maternal survey?

Only clinical information is captured in the medical record. However, we have learned that additional information from the mother and her pregnancy experiences can lead to a better understanding of the course of the pregnancy and its’ outcome.

Why do you need to look at my medical records?

By reviewing the medical records pertaining to your pregnancy(ies), we are able to collect very specific clinical information pertinent to the course of your pregnancy and its’ outcome. The Pregnancy Research Project 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 researchers.

What are the risks?

There is minimal risk in being a participant of the Pregnancy Research Project. The Pregnancy Research Project questionnaire includes questions that can be sensitive, and you may feel uncomfortable answering.  You do not have to share any information you do not want to. Almost every question has an “I Don’t Know” option.  Other possible risks to you may include fatigue and concern about answering personal questions. You may take as much time as you need to complete the questionnaire and may skip questions that you feel are too personal.

What if I decide I do not want to participate after finishing the Pregnancy Research Project questionnaire?

Should you change your mind and wish to withdraw your data from the Pregnancy Research Project, 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 research@starlegacyfoundation.org or by writing a letter to:

Pregnancy Research Project
Star Legacy Foundation
7820 Terrey Pine Court, #80
Eden Prairie, MN 55347

What if I made a mistake when completing my questionnaire? Why can’t I make changes to the answers provided?

Your questionnaire is locked to any changes after you click “submit” in order for us to protect the quality of the information we gather. If you think you’ve made a mistake or recently learned of new information that would have impacted your responses, simply email the Pregnancy Research Project at research@starlegacyfoundation.org for assistance.

How can I provide the Pregnancy Research Project with an update on my/my child’s health or a new pregnancy?

The Pregnancy Research Project is most valuable when your information is kept up-to-date.  Return to the Pregnancy Research Project website and select “Provide an Update”.  You will need your assigned ID number and password.  From there you have the option to provide a health update for you or your child or add a new pregnancy.

How can I retrieve my username or password to log-in to The Pregnancy Research Project?

Send an email to the Pregnancy Research Project Coordinator at research@starlegacyfoundation.org to report lost log-in information.  She will respond to you within one business day with your username and a temporary password.  When you log back in, you will be prompted to change your password.

I’m very anxious to know how the Pregnancy Research Project is doing. Is there a way to keep in touch?

Yes, of course!  We will keep the Pregnancy Research Project website updated and will also be distributing a newsletter to keep everyone up to date on the progress of the Pregnancy Research Project.  Sign up for the email newsletter here.

Is there anything else I can do to help?

Absolutely!  It is important that we enroll as many pregnancies into the Pregnancy Research Registry.  Please help us spread the word to other women who might consider participating.  Also, please tell your healthcare provider and other health professionals about the Pregnancy Research Registry and encourage their support.

And finally, the costs to maintain and continue the Pregnancy Research Project are significant.  Your donations are always appreciated.  If you would like to help Star Legacy Foundation raise the important funding by holding a Champions event, please contact us at champions@starlegacyfoundation.org or call 952-715-7731.

 

 

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