Questions and Answers

Questions and Answers
About the Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS)
One in every 33 babies
in the United States is
born with a birth defect.
Birth defects are one of
the leading causes of
death in the first year of
life and can affect how a
child’s body looks, works,
or both. While we know
the causes of some birth
defects, we do not know
what causes most of
them. Researchers across
the nation are teaming
up with the Centers for
Disease Control and
Prevention (CDC) to find answers through the Birth Defects
Study to Evaluate Pregnancy exposureS (BD-STEPS).
What is BD-STEPS? BD-STEPS is a nationwide effort to find
causes of birth defects by collecting information from women
who have recently been pregnant. We study many different
types of birth defects, including cleft lip, spina bifida, and
heart defects.
How does the study work? We talk to women who had
pregnancies affected by birth defects as well as women
whose pregnancies were not affected by birth defects. We
ask about their pregnancy experience and health. We also
want to study the role genetic (inherited) factors play in
the health of a baby. That is why we ask some mothers to
participate in a second part of the study that includes giving
approval for us to use a small amount of leftover heel stick
blood that was already collected from the baby at birth.
Why do you need information about genes? We hope
to study genetic material to see if certain forms of genes are
more likely to be present when birth defects occur.

U.S. Department of Health and Human Services
Centers for Disease Control and Prevention

Who funds the study? CDC funds the Centers for Birth
Defects Research and Prevention (CBDRP) that work together
on the study. Participating CBDRP sites include: Arkansas,
California, Georgia (CDC), Iowa, Massachusetts, New York
and North Carolina.
How did you get my name? Birth defects are a serious
public health concern, and state laws allow each study site to
collect information on pregnancies affected by a birth defect.
This is how most women are identified in the study. Women
whose pregnancies were not affected by birth defects are
chosen from women who gave birth in the same year.
What will the results show? Since the study looks at a
large group of women, this means findings will apply to “the
average woman” rather than any specific individual. There are
many possible results. We may uncover:
• Risk factors, things that raise the risk for birth defects
• Protective factors, things that lower the chances of
having a baby with birth defects
• Neutral factors, things that neither raise nor lower the risk
What will you do with the study findings? We publish
findings in medical journals. Because birth defects are of
great interest, findings are often covered in the news as well.
We also will publish findings in a yearly electronic newsletter
that we will make available to women who take part in
the study.
Why is this study so important? Understanding the causes
of birth defects can help us prevent them. The size and scope
of this study will provide important clues to help us in our
journey to ensure that every child is born with the best
health possible.

Questions and Answers
What You Need to Know About Participating
What does the study involve?
1. An interviewer will call you in about one to two weeks
to begin the interview or set up a good time for the
interview. The interview lasts about 55 minutes, and
it can be split into segments to fit your schedule.
2. After the interview is complete, we hope you will
participate in more parts of the study. You will
receive separate mailings for each part of the study
where you qualify.
Where is the study conducted? You can participate in all
parts of the study from your home or any private location
you choose.
How will the study benefit my family? Study results will
not directly benefit you or your family. However, many
women feel good about helping to find causes of
birth defects.
Are there any disadvantages to participating? Some
women interviewed find it emotionally difficult to discuss
their pregnancies. There is no other likely disadvantage.
What do I get for participating? We have enclosed a
$20 gift card as a token of appreciation for your time and
interest. The gift card is yours to keep whether or not you
take part in the interview. If you choose to participate in
the study, you have a chance to receive more gift cards.

We will ask about the following things in your interview:
your recent pregnancy and the month before you became
pregnant, past pregnancies, your general health, family
background, lifestyle, work, and prescription and nonprescription medicines taken. We will also ask a few
questions about your baby’s father. Please look at the
medicine sheet in this packet to help you remember
the medicines you took around the time you became
pregnant and in your first trimester.
What if I do not want to answer or can’t remember?
You may skip any questions you wish. It is okay to say
that you don’t remember. We want you to answer as
accurately and honestly as possible.
How will my privacy be protected? We will never use
any names in reports or publications. We will not give any
information about you to anyone who is not an approved
researcher on this study. No one else may look at your
data, including insurance companies, even if requested
by a court of law. We keep records under lock and key. All
computer files are password protected.
Study contact information. If you have any questions,
please feel free to call us at our toll free number,
1-888-743-7324 or email us at questions@bdsteps.org.
You can also visit www.bdsteps.org for more information
about the study. To reach local researchers, use the
following information:

Do I have to participate? No. There will be no harmful
effects if you refuse. Your decision will not affect health
care services or other benefits you or your family
may receive.
What will I be asked in the interview? The interview
covers a wide range of topics about you and your
pregnancy. Sometimes we ask you to answer in your own
words. Other times, we will give you several possible
responses to choose from.

July 19, 2019

CS309490-A