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Utilization of Products for the Development of the Pregnancy Safety Study Framework Among Mothers with Live-Birth Deliveries: A Descriptive Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    products for the development of the pregnancy safety study framework
    Health Outcome(s)
    use in pregnancy
    Description

    In this report, we describe the utilization of various medical products during pregnancies ending in live-birth delivery in the Sentinel Distributed Database (SDD). Medical products of interest (MOIs) include those with pregnancy‐related postmarketing requirements (PMRs) and/or postmarketing commitments (PMCs), those involved in pregnancy registries, or those investigated in studies listed in ClinicalTrials.gov that fulfilled the following search criteria elements with respect to their use during pregnancy: 1) Pregnant, Pregnancy, Observational, 2) Limited to studies associated with a drug or biologic.

    We distributed this request to five Sentinel Data Partners on January 12, 2023. The study period includes data from January 1, 2008 to June 30, 2022.

    A companion analysis describes utilization of various medical products during pregnancies ending in live-birth delivery where the mother is linked to a singleton infant in the Sentinel Common Data Model (SCDM) Mother‐Infant Linkage (MIL) table.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2008 - June 30, 2022
    Analysis Type
    Descriptive
    Population / Cohort
    Females 10 to 54 years of age with evidence of a live-birth
    Data Sources
    Sentinel Distributed Database (SDD)