Medication use in pregnancy and birth outcomes program uri icon
  • 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.

  • publication date
  • 2009
  • Research
  • Drugs
  • Ob Gyn
  • Outcomes
  • Pregnancy
  • Women's Health