Study Components

The Birth Defects Study To Evaluate Pregnancy exposureS (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:

• Observational: The study is observational because it 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 analyze the information from the interviews.
• Population-based: 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 counties within a state.
• Case-Control: 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 by telephone. Interviewers talk with mothers 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 these women about their pregnancy experience and general health.

We might also ask for consent to request a leftover newborn blood spot that was collected shortly after birth or to review information on notifiable infectious diseases.