National Birth Defects Prevention Study
About the Study....
The National Birth Defects Prevention Study is a nationwide effort to discover birth defects' causes. Eight birth defect programs designated as "Centers for Birth Defects Research and Prevention" are located throughout the country. They are in Arkansas, California, Georgia, Iowa, Massachusetts, New Jersey, New York, and Texas. Many different types of birth defects are being studied. The study will look at a large group of women which will enable the findings to be applied to "the average woman", rather than any specific individual. We may uncover risk factors that contribute to birth defects, protective factors that lower the chances of having a birth defect, or neutral factors that neither raise nor lower the risk. The findings will be published in medical journals and may also be used in health education material.
In New York...
- Case ascertainment will take place in two areas of New York State: the lower Hudson Valley region and the Western New York region, including Buffalo.
- Cases are located through the areas' hospitals which have obstetrical services, perinatologists, genetic centers, obstetricians, midwives and prenatal clinics. The project specialist is responsible for ascertaining the cases at these data sources, screening them to insure case criteria are met, and reviewing the records.
- Controls are randomly selected from births without major malformations.
- In order to obtain detailed history beyond what is generally available through records, the participation in an interview process is requested of a select number of women. The physician or caregiver of the selected case is contacted by mail to inform them of the desire to interview his/her patient. A brochure is made available to the patient for her review to enable her to make an informed decision regarding participation in the interview. The standardized interview includes questions about the patient's recent pregnancy, past pregnancies, health, diet, family history, work, hobbies and lifestyle. It is conducted by telephone.
- Some women interviewed may be asked to participate in a second part of the study involving genetic testing.
Confidentiality...
All information collected is kept confidential. Employees involved in this project are subject to the confidentiality procedures set forth in the "Personal Health Information Confidentiality Protocol" of the New York State Department of Health's Center for Environmental Health and Health Research Institute. Identity of the women and their offspring is not used in any report or publication, nor is it shared with anyone outside the study, including insurance companies or governmental agencies. Records are kept under lock and key. Identifying information is removed from computer files, which are password protected.
For specific questions regarding the National Birth Defects Prevention Study in New York State, please contact the Project Director, Dr. Charlotte Druschel at (518) 402-7990 or (800) 458 -1158 ext 2-7990.
