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PREGNANCY RESEARCH PROJECT
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.
What is considered a poor pregnancy outcome?
Any pregnancy that does not end with a healthy mother and health baby is considered a poor outcome.
How will the Pregnancy Research Project help research?
Enrolling a large number of women who have had a pregnancy or who are currently pregnant is essential to answer questions about risk factors for poor pregnancy outcomes. For example, since stillbirth occurs in about 6 out of every 1,000 births in the United States, studies in any given hospital will take many, many years and be logistically very challenging to enroll enough women to be able to look at different risk factors. However, by hosting an online study we can reach thousands of women in a short time period which means that researchers can investigate many risk factors and be able to answer questions that many hospital-based studies cannot.
Who can participate in The Pregnancy Research Project?
We are collecting data from individuals:
- Currently at least 18 years old AND
- have ever delivered a stillborn baby in the past OR
- delivered a living baby in the last 5 years (regardless of how long the baby may have lived) OR
- are currently pregnant at 12 or more gestational weeks
Can I participate in the Pregnancy Research Project more than once?
Yes! You can participate for each of your pregnancies that meet the abov e criteria. For example, if you had a stillbirth previously, have a 2 year old at home and are currently pregnant, you could participate three times!
What happens in the study?
Women will be invited to complete an online survey about their health and behaviors during pregnancy. This will include questions about any medical conditions or diagnoses, information about hospital or clinic visits, any medications, general health and wellbeing, as well as women’s thoughts and perceptions about their pregnancy.
After the survey, women will asked if they would like to share their medical records with the research team. This is not required but will be helpful for the research team to understand the documented health information at each visit (such as blood pressure and glucose levels), number of ultrasounds, and medical tests that were performed. Women will have to provide additional consent for release of medical records to the research team. You can download and print the Medical Record Release form here.
If women agree to release medical records, 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 relating to the pregnancy. 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 survey portion of the Pregnancy Research Project is available to participants anywhere in the world. We plan to expand the Pregnancy Research Project to non-English speaking mothers and medical records that are not in English in the future.
I am currently pregnant. Why can I only participate at 12 or more weeks?
We would like women to wait until at least 12 weeks of pregnancy before enrollment. Most times, pregnancies are not confirmed by obstetrical care providers prior to 12 weeks. If you want to enroll, please wait until you are at least 12 weeks!
I lost my baby before 12 weeks of pregnancy; why can’t I take part?
We are certainly concerned about all pregnancies, however, this project depends upon comprehensive data, which is not typically available in very early pregnancy. Furthermore, since part of this project invites women to allow access to their medical records, before 12 weeks medical records on the pregnancy don’t exist or if they do, very little information is available. We will be updating the criteria as medical practice and technology changes.
Who do I call if I have questions about the Pregnancy Research Project?
You can call Star Legacy Foundation at 952-715-7731, ext. 6 or email at email@example.com. You may also call Michigan Medicine at 734-763-9684.
Will you collect any blood or other biological samples for research (such as genetic testing)?
No. If you consent to the use of your medical records and genetic test results are included in your medical records, they will be able to be seen by the researchers. But no new testing or samples will be collected.
Will anyone else know my name?
By taking part in the survey, none of your identifying details will be recorded. We will not even ask your name. However, if you agree to release your medical records to the research team then your name and other identifying details will be known. However, once the relevant information has been obtained from your medical records, your records will be securely destroyed by Michigan Medicine.
In the research database, 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.
In the future with appropriate permissions, and when there is sufficient information, approved scientists, researchers, and clinicians may be able to request access to the data. However, this data will be deidentified and nobody will know who you are. As long as your information is kept within the University of Michigan Health System, it is protected by the Health System’s privacy policies. For more information see http://www.med.umich.edu/hipaa/npp.htm. 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).
Can insurance companies access my medical information and/or my participation in the Pregnancy Research Project?
No. Non-one other than the study team has access to the study information. 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.
What are the risks?
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. You do not have to share any information you do not want to. 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.
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 firstname.lastname@example.org for assistance.
Can I enter additional/new pregnancies?
Yes! Any pregnancy that meets the criteria is helpful. Feel free to complete the information for each of your eligible pregnancies or return if you are pregnant again in the future. Please note that a new survey is required for each pregnancy as you can only complete the survey for one pregnancy at a time.
Are other organizations supportive of the Pregnancy Research Project?
Yes! We have numerous other organizations that share our enthusiasm for this project. The home page of the Pregnancy Research Project includes a current list of those organizations.