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Utilization of Products Over Time 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 identified pregnancies ending in live birth delivery in the Sentinel Distributed Database (SDD), and described medical products of interest (MOIs) utilization during pregnancy for select MOIs with pregnancy-related postmarketing requirements, requirement(s) and/or commitment(s), those involved in pregnancy registries, or those investigated in clinical trials with respect to their use during pregnancy. 

We distributed this request to six Sentinel Data Partners on August 4, 2023. The study period includes data from January 1, 2008 to January 31, 2023.

Deliverables (1)
Sentinel Modular Program Report: Utilization of Products Over Time for the Development of the Pregnancy Safety Study Framework Among Mothers with Live-Birth Deliveries: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2008 - January 31, 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
Presentation: Analysis of Medicinal Product Utilization Data in the FDA Sentinel System to Inform the Development of a Pregnancy Safety Study Framework