If you cannot find answers to your questions below, please visit our CONTACT US page and send us your question.
About the Study
- What is the B-WELL-Mom study all about?
- What will the study tell us?
- Who is running the study?
- I am eligible for the study, how do I participate?
- Why is it important for me to continue to help the B-WELL-Mom study?
- Is the research only about asthma? I don’t have asthma, why should I participate?
- How will information learned from the B-WELL-Mom study be shared and how will the information provided be used to benefit health?
- What are my benefits as a participant?
- How long will the study last?
- Who makes sure this study is safe and scientifically sound?
- What if I change my mind after I signed up to participate?
- I am interested in being part of the study, but I don’t think I will have enough time for all aspects of the study.
- What happen if I move, or change my phone, or email address while I’m in the study?
Study Follow-up Activities
- How often do I have to come in?
- How long is each follow-up visit?
- What is the purpose of the follow-up questionnaires? Why do I have to give more information?
- How will I get the results of the study?
- Can I get the results of any of my tests?
Privacy and Confidentiality
- Will my information be kept confidential, how will this be done?
- What will you do with my information?
- Will my insurance company or employer obtain the information I gave you as part of the study?
- Will I have to provide any medical records?
- Why do you need details from my medical records?
Find Out More
- How can I learn more and have my questions answered about the B-WELL-Mom study?
- Where can I find out more about pregnancy in general, or information about asthma?
About the Study
What is the B-WELL-Mom study all about?
B-WELL-Mom aims to learn more about the biologic and environmental factors that can affect changes in asthma symptoms throughout pregnancy. It also aims to study basic immunology of pregnancy, which is currently not well-understood. The study specifically examines how allergy, air quality, and diet can affect lung function and inflammation throughout pregnancy among pregnant women with asthma and those without.
What will the study tell us?
We will learn more about the biologic and environmental factors that change lung function and inflammation during pregnancy. This will help us understand more about changes in asthma symptoms throughout pregnancy as well as how women without asthma adapt to the biologic stresses of pregnancy. We hope that this information will help improve care for pregnant women with asthma, who often experience higher rates of complications like high blood pressure and preterm birth, as well as improve our understanding of maternal immune function during pregnancy for all women. A successful maternal immune response is key to the baby’s normal growth and development.
Who is running the study?
Researchers from the National Institute of Child Health and Human Development, University of Alabama Birmingham, and Northwestern University, and the Emmes Corporation are running this study.
The investigators are:
- Dr. Pauline Mendola, National Institute of Child Health and Human Development
- Dr. William Grobman, Northwestern University
- Dr. Joseph Biggio, University of Alabama, Birmingham
- Dr. Seth Sherman, Emmes Corporation
For more detailed information about the investigators leading the study, please visit the “Who is leading the study” tab.
I am eligible for the study, how do I participate?
If you are eligible for the study according to the eligibility criteria, and are interested to participate, please contact the following people:
If you are in the University of Alabama Birmingham area, please contact Mickey Parks at (205) 934-4374 or firstname.lastname@example.org
If you are in the Northwestern University area, please contact Kaitlin Wolfe at (312) 503-3248 or email@example.com
Why is it important for me to continue to help the B-WELL-Mom study?
We know that a successful maternal immune response is key to getting pregnant and having a healthy mom and baby. But we know very little about how the immune system does that job well. This information will be important to help us understand what goes wrong when asthma symptoms get worse or when complications arise in a pregnancy that could potentially be treated. Your participation in the study is vital to helping us learn about what drives these changes for pregnant women. This information can help doctors to improve care and treatments for women during pregnancy.
Is the research only about asthma? I don’t have asthma, why should I participate?
Although a big part of this project involves pregnant women with asthma, it is not only about asthma. About one third of the participants enrolled in the study have no history of asthma. This group will teach us the most about immune function, lung function and inflammation in normal pregnancy – areas where we know surprisingly little. For example, as pregnancy progresses the baby takes up more room and sometimes it can be harder for moms to breathe – whether they have asthma or not. Your measurements as a non-asthmatic mother will be very useful since most pregnant women (about 90%) do not have asthma but still might have other pregnancy complications like preterm birth or hypertension.
How will information learned from the B-WELL-Mom study be shared and how will the information provided be used to benefit health?
The results from B-WELL-Mom will be reported in scientific papers, including journals read by doctors and other healthcare providers. Results will also be reported in the national and regional press, and directly to the participants in newsletters and on this website. Published summary reports from the study will also be available to government and other organizations that make decisions related to risk factors for poor immunologic responses during pregnancy, and to those who make policy recommendations. Also, these reports will be available to other investigators who may wish to test ways to prevent disease.
What are my benefits as a participant?
Although you will not have any direct benefit from the study, you will get some incentives including a tablet computer to enter study data that will be yours free of charge at the end of the study. You will also be compensated for your time and other costs for study visits and filling out the diary questionnaire. Your information will contribute to new knowledge on lung function, inflammation and asthma control during pregnancy, which will have important impact for all pregnant women.
How long will the study last?
The whole study is expected to be 2.5 years long. Your time commitment starts from your first enrollment visit (
Who makes sure this study is safe and scientifically sound?
Research funded by the federal government is always carefully reviewed and monitored by experts from different fields. First, Institutional Review Boards (IRBs) review the study, identify issues and/or concerns related to scientific quality and safety, and works with investigator to improve the study if needed. The study protocol/plans receive review at least once a year at each clinical site and at the data coordinating center to ensure that the study is scientifically sound and that your confidentiality and rights are protected.
What if I change my mind after I signed up to participate?
You are free to withdraw from the B-WELL-MOM study at any time. This will not affect your care in any way. If do not want to be part of the study anymore, please contact your study coordinator by using the CONTACT US page.
I am interested in being part of the study, but I don’t think I will have enough time for all aspects of the study.
Your full participation in the study is very important to us because it allows us to collect the detailed information needed to answer various study questions. However, we understand your concern, so we have an option that allows visit-only participation. This option allows you to be part of the study without providing daily information. However, we would ask that you come in for two additional short visits so that we can obtain updates on your health status.
What happen if I move, or change my phone, or email address while I’m in the study?
Please let your study coordinator know as soon as possible. Whenever possible, we try to maintain your participation and many study measures can be done remotely.
Study Follow-up Activities
How often do I have to come in?
After the first enrollment visit, we ask you to come in three more times, two more times during pregnancy (around weeks 20-22 and weeks 30-32) with the final study visit 4 months after delivery. Some women may come in for supplemental visits but that is not common.
How long is each follow-up visit?
The first enrollment visit typically takes about 2 hours. The follow-up visits are shorter and typically last around one hour.
What is the purpose of the follow-up questionnaires? Why do I have to give more information?
We ask a fairly comprehensive set of questions that relate to your and your baby's health at enrollment. After that, we are interested in how things change over time, so the questions are often a bit shorter. The ability to track changes over time is one of the strengths of our study – we can tell how lung function and other measures change over pregnancy and as your baby grows.
How will I get the results of the study?
We will update participants with interesting findings through a periodic newsletter, which will be posted in this website. For the most current newsletter, please visit NEWSLETTER.
Can I get the results of any of my tests?
The tests we will do are for research purposes only. It is possible to get a copy of your test results from your study coordinator but they will write on the papers that the tests are for research purposes only. This is important because the results are not intended to be used as a diagnostic test or to make any health care decision. In addition, some of these tests may not be done any time soon. However, if in the course of any of the testing, we learn something that we believe is important for your health, we will notify your doctor.
Privacy and Confidentiality
Will my information be kept confidential, how will this be done?
Your privacy and confidentially as a participant in this study are among our top priorities. All of the B-WELL-Mom staff sign confidentiality forms and undergo training in research ethics. We have put in place several protections for the privacy of your data. When your data are collected, they are labelled with a unique ID number. After your data are collected, your biologic samples, questionnaires, and interview data are stored separately from all personal identifiers such as your name, address, and phone number. Your personal contact information is kept in separate files accessible only to the study staff at the clinical centers, not at the NIH or at the data coordinating center. You will never be identified in any study reports.
What will you do with my information?
We will compare data provided by women who had poorly-controlled asthma, well-controlled asthma, as well as those with no-asthma. This will help us understand the differences between the two groups, and the predictors for changes in asthma symptoms throughout pregnancy. It will also tell us about how a mother’s immune system changes to support the growth and development of her baby.
Will my insurance company or employer obtain the information I gave you as part of the study?
No. We take multiple measures to ensure confidentiality of your information. There will be no cost to you or your insurance for participating.
Will I have to provide any medical records?
Yes, we ask for your medical records to obtain details about your and your baby’s health. We will do that electronically, so you will not have to submit anything. However, we ask for your consent before we perform any medical records collection.
Why do you need details from my medical records?
Medical records give us detailed information about your and your baby’s health and we primarily use information from your prenatal records and delivery admission. This allows us to assess risk factors more accurately.
Find Out More
If you want to learn more about the study, or your questions are not fully answered by the information on this webpage, please do not hesitate to contact your study coordinator. Their contact information can be found on the CONTACT US page.
Where can I find out more about pregnancy in general, or information about asthma?
Below are some helpful resources about pregnancy and asthma in general:
- PREGNANCY: http://www.cdc.gov/pregnancy/
- ASTHMA DURING PREGNANCY: http://www.marchofdimes.org/complications/asthma-during-pregnancy.aspx
- ASTHMA IN WOMEN: http://www.cdc.gov/healthcommunication/toolstemplates/entertainmented/tips/asthmawomen.html