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Medical Record Release Form

Pregnancy Research Project

You may be eligible to take part in the Pregnancy Research Project, a research study being conducted by Star Legacy Foundation in collaboration with Michigan Medicine. Take time to carefully review this information and decide if you would like to participate.

The goal of the Pregnancy Research Project is to learn about risk factors for poor pregnancy outcomes such as preterm birth and stillbirth. Women who have been pregnant in the past as well as those who are currently pregnant may be eligible.  It was created after many discussions with health are providers, researchers and organizations that have a common goal of improving birth outcomes by collecting epidemiological data.  Unlike many other research studies in small groups of patients, epidemiological studies collect data from large populations and can allow researchers to learn about important risk factors that are linked to specific outcomes and how these outcomes can be prevented. In order to understand why some pregnancies do not end with a healthy baby it is important to compare the experiences and medical information of women who have had a live birth with those who have not. By enrolling in this study you will be helping us better understand why some pregnancies end in stillbirth and other poor outcomes.

Who Can Participate?

You are eligible to participate if:

  • You are currently at least 18 years of age or older
  • You have had a stillbirth (pregnancy loss at or after 20 weeks gestation) at any time in the past
  • You have delivered a baby within the last five (5) years
  • You are currently pregnant at 12 weeks gestation or more

What will happen?

You will be invited to complete an online survey that will take about 30 minutes. The survey is also available in print format or a nurse can ask you the questions over the phone if you prefer.  The questions will ask about your pregnancy experience, healthcare provider visits you may have had, medical conditions you had before pregnancy and those which developed during pregnancy. If you are currently pregnant, we may ask you to complete another survey in late pregnancy and again after delivery.

You will also have an option to allow the researchers to review your pregnancy medical record. This will only occur with your permission and you do not have to agree to this. You can still participate in the survey even if you do not wish to allow access to your medical record. If you do give us permission to request your medical records, you will be asked to complete and sign a document that will then be given to the hospital and clinic where your medical records are located.  Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).  This type of information is called protected health information (PHI).  PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your maternity care, including: prenatal records, ultrasound or other medical images, laboratory test results, hospital and delivery records, and information about your baby’s first days if your baby was born alive or about cause of death if your baby was stillborn. Click to download and print the  Medical Record Release form.

How many women will participate?

We anticipate that thousands of women from all over the world will take part.

What will happen to my information?

All information will be kept strictly confidential. The survey that you complete will be stored on a secure server behind Michigan Medicine firewalls and can only be accessed by the study team. You will be assigned a unique ID number and no identifying details will be used when the researchers analyze the data.

If you give permission for the study team to access your pregnancy medical record, the permission request will be sent to the hospital/clinic that cared for you and delivered your baby.  Only once those facilities has received your permission can they send the records to Star Legacy Foundation. Trained health professionals will abstract the necessary data and enter it into a secure database that is located on Michigan Medicine servers. These servers are secure and nobody outside of the study team can access your information. Once the data from your medical record has been obtained, a scanned copy of the medical record will be stored on the secure servers at Michigan Medicine and any hard copies will be confidentially destroyed (shredded).

What will the researchers do with my information?

The international study team has worked together for many years to investigate why some pregnancies end in devastating outcomes such as stillbirth. While together we have learned about several new risk factors for poor pregnancy outcomes, in order to better understand how these factors impact pregnancy, we need to enroll much larger populations of women.  Furthermore, our previous studies were based on maternal recall of their pregnancy experience. While this is critically important, our previous work did not include the ability to review the pregnancy or delivery record for important medical information. The current study will also include – with your permission – a review of your medical record during your pregnancy and delivery. You do not have to agree to this to take part. However, allowing access to this information will provide the researchers with important information that may impact the findings of the study.

It is important to know that all of your information (surveys as well as any medical information) will be held securely in one place at Michigan Medicine, (part of the University of Michigan). An ID code will be assigned to your data and when the researchers analyze results, only the ID code will be available. None of your identifying information will be included.

What are the risks of taking part?

With all research there is a potential risk of breach of confidentiality. However, we will minimize this by assigning a unique ID to every participant. Identifying information is removed so that no-one except the study team knows who you are. For women who have had a pregnancy loss or a difficult pregnancy, it is also possible that completing the survey may trigger memories that could be upsetting.  We have provided a free phone number at the end of the survey if you would like to talk with a professional counselor.

As with any research study, there may be additional risks that are unknown or unexpected.

How could I benefit if I take part in this study? How could others benefit?

You may not receive any personal benefits from being in this study. However, others may benefit from the knowledge gained from this study.

Can I take part in other studies?

Several researchers around the world are involved in the Pregnancy Research Project. These researchers often have other studies that you might be able to participate in. You may choose to be contacted by the Pregnancy Research Project if we learn of studies you might be eligible for that require additional information. You will not be obligated to participate in future studies, you will only be made aware of them and provided instructions on participation if you so wish.

What if I want to stop participating in this study?

You are free to leave the study at any time. Your data up to the point of withdrawal may be used unless you specifically request otherwise. Please be aware that once the data has been de-identified, the study team will no longer be able to identify your record and remove data. If you choose to tell the researchers why you are leaving the study, your reasons for leaving may be kept as part of the study record.

Thank you for contributing to science, public health, and medical research. Working together, we can make discoveries that will positively affect health outcomes for mothers and babies for many generations to come.

For more information, contact us at [email protected] or call 952-715-7731, extension 6 OR toll free 800-357-6486, extension 6.


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