Research Program in Medication Use and Outcomes in Pregnancy (MEPREP)


This research program develops infrastructure to enhance our ability to study the effects of medication exposure during pregnancy on the fetus by creating and maintaining linked data on mothers and infants. Cohorts of women delivering an infant and their children have been identified from two FDA contract sites using large automated databases that include membership, pharmacy, inpatient, and outpatient information. These sites include the Health Care Systems Research Network (with a subcontract to the Vanderbilt University School of Medicine) and Kaiser Permanente in California. Approximately 90,000 analyzable births per year are identified from these sites.  

Specific components of the program include:

  • Maternal-infant record linkage of all women delivering an infant between 2001 and the most recent date available
  • Linkage to birth certificate data and death certificate data
  • Development and maintenance of data files on maternal and child enrollment, outpatient drug dispensings, and inpatient and outpatient diagnoses and procedures, in addition to specific data elements obtained from birth certificate data (e.g., gestational age, maternal smoking status)
  • Validation of data elements within the datasets, including diagnoses/birth outcomes reported in administrative data as well as data elements included in the birth certificates, through medical chart abstractions
  • Potential linkage of the datasets to other internal (e.g. electronic health record) and external datasets (e.g. cancer registries)

Related Publications



Related Links

Centers for Education and Research on Therapeutics

HMO Research Network

Principal Investigators: Richard Platt, MD, MSc, Darren Toh, ScD


Funder: Food and Drug Administration

Project Leader: Susan Andrade