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Utilization of Products with Labeling Changes Related to Pregnancy Among Mothers with Live-Birth Deliveries: A Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
products with labeling changes related to pregnancy
Description

In this report, we identified pregnancies ending in live birth delivery in the Sentinel Distributed Database (SDD), and assessed utilization during pregnancy for selected 120 medical products (MP) with labeling changes related to pregnancy.

The study period includes data from January 1, 2008 to September 30, 2023. We distributed this request to 13 Sentinel Data Partners on February 29, 2024.

Deliverables (1)
Sentinel Modular Program Report: Utilization of Products with Labeling Changes Related to Pregnancy Among Mothers with Live-Birth Deliveries: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2008 – September 30, 2023
Analysis Type
Descriptive
Population / Cohort
Females 10 to 54 years of age with evidence of a live birth
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Analysis: Utilization of Products for the Development of the Pregnancy Safety Study Framework Among Mothers with Live-Birth Deliveries: A Descriptive Analysis
Sentinel Drug Analysis: Utilization of Products for the Development of the Pregnancy Safety Study Framework Among Mothers Linked to Live-Birth Deliveries in the Mother-Infant Linkage Table: A Descriptive Analysis
Sentinel Drug Analysis: Utilization of Products Over Time for the Development of the Pregnancy Safety Study Framework Among Mothers with Live-Birth Deliveries: A Descriptive Analysis