Background/Aims: Our knowledge of safe medication use during pregnancy is limited, due primarily to the lack
of rigorous studies evaluating birth outcomes associated with in utero exposure to medications. A collaborative
research program, the Medication Use in Pregnancy and Birth Outcomes Program, between the Food and Drug
Administration (FDA) and researchers at the HMO Research Network Center for Education and Research in
Therapeutics (CERT), Kaiser Permanente Northern and Southern California, and Vanderbilt University, aims to
develop common, necessary data linkages to enable the conduct of multiple studies of medication use and
outcomes in pregnancy across participating sites.
Methods: Specific components of the program include: 1) maternal-infant record linkage of all women delivering
an infant between 2001 and 2007, 2) linkage to birth certificate data for infants delivered between 2001 and
2007, 3) validation of data elements within the datasets through medical chart abstractions, and 4) annual update
of the datasets.
Results: This collaboration will provide a large ethnically and geographically diverse population, with
approximately 90,000 births per year. Data files on maternal and child enrollment, outpatient drug dispensing,
and inpatient and outpatient diagnoses and procedures, in addition to data elements obtained from birth
certificate data, will be developed and maintained at each of the program sites. The proposed poster will
describe the program and the available standard file definitions and data elements.
Conclusions: The program will be an important resource for the evaluation of birth outcomes (birth defects and
other perinatal events) associated with medication use during pregnancy, patterns and trends in medication use
during pregnancy, and studies of the risks and benefits of medication use for the pregnant women themselves.