Details
Pregnant women are rarely included in clinical trials. Yet, pregnant women may choose to continue medical treatment during pregnancy, particularly for chronic conditions. Therefore, FDA’s capacity to study medical product exposures during pregnancy on maternal and infant outcomes is important to monitor the safety of medication use during pregnancy. Pregnancy registries or postmarket observational studies typically are used to evaluate the safety of medication use during pregnancy.
The purpose of this study was to characterize the demographics, health characteristics, and drug utilization of infants and mothers included in the Sentinel Distributed Database (SDD) Mother-Infant Linkage (MIL) table. The study additionally characterized infants and pregnant females not included in the MIL table. These were infants who had not been linked to a mother, mothers with a documented singleton birth but without linkage to her infant and pregnant females with a non-live birth outcome.
For the infant component, using data from the MIL table for both Medicaid and non-Medicaid data sources, we characterized about 5.4 million infants with matched mothers and 17.4 million without matches. The maternal component provides extensive data on comorbidities, drug use, and pregnancy characteristics for more than 6.7 million live birth and 3.2 non-live birth deliveries. No regulatory outcomes were intended for this study as it was designed for purposes of describing the infant and maternal groups included in the SDD MIL table.