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.
We’re doing a study to learn more about risk factors for poor pregnancy outcomes such as preterm birth and stillbirth. In order to understand why some pregnancies do not end with a healthy baby it is important to compare the experiences and health 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 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?
We would like you to answer a survey about your health practices during pregnancy. 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. We expect it to take about 20-30 minutes to complete the online survey.
Answering this survey about your pregnancy and general health is voluntary. You don’t have to answer it if you’d rather not. You can skip any questions that you don’t want to answer, whatever the reason, and you don’t have to tell us why. Choosing not to answer our survey won’t affect the medical care you might receive at the University of Michigan Health System.
It’s possible that some of the questions may make you feel uncomfortable. If a question makes you uncomfortable, you can just skip it and go to the next question.
How many women will participate?
We anticipate that at least 5,000 women from all over the world will take part.
What will happen to my information?
All information will be kept strictly confidential. To keep your information confidential, we will store the information with a unique ID code. 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.
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.
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.
With appropriate permissions, your collected information may also be shared with other researchers, here, around the world, and with companies.
Your identifiable private information may be stripped of identifiers and used for future research studies or distributed to another researcher for future research studies without additional informed consent.
Research can lead to new discoveries, such as new tests, drugs, or devices. Researchers, their organizations, and other entities, including companies, may potentially benefit from the use of the data or discoveries. You will not have rights to these discoveries or any proceeds from them.
Agreeing to participate in this study gives the researchers your permission to obtain, use, and share information about you for this study, and is required in order for you to take part in the study. Your permission expires at the end of the study, unless you cancel it sooner. You may cancel your permission at any time by contacting the researchers listed below (under Contact Information).
It’s possible that the researchers or others will need access to information about you during or after this study. For example:
- The researchers may need the information to make sure you can take part in the study.
- The researchers may need the information to check your test results or look for side effects.
- The University of Michigan or a government agency may need the information to make sure that the study is done in a safe and proper manner.
- Study sponsors or funders, or safety monitors or committees, may need the information to, make sure the study is done safely and properly, learn more about side effects, or analyze the results of the study.
- The researchers may need to use the information to create a databank of information about your condition or its treatment.
- Federal or State law may require the study team to give information to the Food and Drug Administration (FDA) or other government agencies. For example, to prevent harm to you or others, or for public health reasons.
The results of this study could be published in an article, but would not include any information that would let others know who you are.
As a rule, the researchers will continue to use information about you until the study is over and will keep it secure until it is destroyed. Limited information about you may continue to be used after the study is over, for other research, education, or other activities. But use of this information would not reveal your identity.
As long as your information is kept within the University of Michigan Health System, it is protected by the Health System’s privacy policies. Note that once your information has been shared with others, it may no longer be protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).
At the end of the survey 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. More information about this can be found after you have completed the survey.
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 734-763-9684 OR
[email protected] or call 952-715-7731, extension 6 OR toll free 800-357-6486, extension 6.
You may also express a concern about a study by contacting the Institutional Review Board:
University of Michigan Medical School Institutional Review Board (IRBMED)
2800 Plymouth Road
Building 520, Room 3214
Ann Arbor, MI 48109-2800
734-763-4768
E-mail: [email protected]
If you are concerned about a possible violation of your privacy or concerned about a study, you may contact the University of Michigan Health System Compliance Help Line at 1-866-990-0111.
