Study Components

BD-STEPS is a research study that builds on the success of the National Birth Defects Prevention Study (NBDPS). Research involves collecting information in an organized way to answer specific questions about a certain topic. The collected information is then analyzed to answer the questions that were asked. Because the study is done in a structured and systematic way, we have some proof that the answers we find are true. More specifically, BD-STEPS is an observational, population-based, case-control study. What does all this mean? Let’s break down each of these terms:

  • The study is observational because it simply looks at what is already going on. It does not test medicines or treatments or ask people to do anything differently. In BD-STEPS, women are interviewed and researchers then analyze the information from the interviews.
  • BD-STEPS is population-based because it looks at all people with a certain health outcome who live in a certain area. That area could be a state or a number of counties within a state.
  • BD-STEPS is a case-control study because information is collected from both people who have a health issue (cases) and people who do not have the health issue (controls). The controls might also be called the comparison group. In BD-STEPS, controls are selected randomly from birth certificates or records of birth hospitals.

The main part of the study involves interviewing women on the telephone. Interviewers talk with women who have had a pregnancy affected by a birth defect, as well as with mothers of babies who do not have a birth defect. The interviewers ask women about their pregnancy experience and general health.

We might also ask for your consent to request a leftover newborn blood spot that was collected shortly after the birth of your child, for your consent to review some of your medical records, and perhaps to participate in an on-line survey or saliva collection.