The purpose of BD-STEPS is to identify modifiable maternal exposures in early pregnancy that may increase the risk for having a pregnancy affected by certain major, structural birth defects. The specific aims of the NCCBDRP are to (1) Implement the standardized BD-STEPS protocol as the NC BD-STEPS, including (a) use the NC birth defects surveillance system to identify 244 cases (among livebirths, stillbirths and induced abortions) in the study area each year with one or more of the 17 birth defects included in the study protocol; (b) identify a random sample of 96 control infants per year using birth certificates; (c) conduct clinical review for case classification and confirmation using abstracted medical records and other information;(d) conduct all advance and follow-up mailings to potential participants including kits for self-collection of saliva, and provide contact information to the central interviewing agency; (e) obtain consent from participants to abstract medical records; and (f) obtain residual newborn blood spots from the North Carolina State Laboratory. (2) Provide substantive expertise for the innovative design of BD-STEPS interview questions, survey methods and novel study instruments including targeted online modules related to early pregnancy exposures such as diet, obesity, physical activity, infertility, occupation and chronic medical conditions; (3) Develop innovative study questions and proposals using BD-STEPS and NBDPS data to identify modifiable risk factors for birth defects with maximum potential for public health impact, analyze genetic factors, conduct rigorous analyses, present findings at national meetings, and publish at least 10 papers during the 5-year award period; (4) Provide expertise on epidemiologic and biostatistical methods such as bias analysis, missing data, correlated exposures, pooled samples genetic approach for gene sets, multiple SNPs, haplotypes, GWAS and epigenetics; (5) Conduct innovative laboratory research to develop innovative methods for using dried blood spots to investigate potential risk factors for birth defects including toxic metals and other exposures; (6) Participate in collaborative activities and research initiatives with other CBDRP and the CDC; and (7) Continue to train junior researchers in the field of birth defects epidemiology. By including multiple study sites, BD-STEPS will aim for a study population that is representative of the US population in racial/ethnic composition.
|Effective start/end date||9/1/13 → 8/31/18|
- Centers for Disease Control and Prevention (CDC)
Dried Blood Spot Testing
Genome-Wide Association Study
Centers for Disease Control and Prevention (U.S.)
Statistical Factor Analysis
Single Nucleotide Polymorphism