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Developing and refining methods to assess medical product utilization, safety, and effectiveness during pregnancy is a focus of FDA’s Sentinel System. The Sentinel Common Data Model (SCDM) includes a Mother-Infant Linkage (MIL) table that enables routine evaluation of the effects of medical product exposures during pregnancy on infant outcomes. Descriptions of efforts led by the Center for Drug Evaluation and Research are shown below. Please visit the links to learn more about each area of activity.

Title Date
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 09/15/2023
Utilization of Products for the Development of the Pregnancy Safety Study Framework Among Mothers with Live-Birth Deliveries: A Descriptive Analysis 09/15/2023
Bevacizumab and Other Cancer Medication Use in Pregnant Patients: A Descriptive Analysis 08/04/2023
Assessing Medical Product Safety During Pregnancy using Parameterizable Tools in the Sentinel Distributed Database 11/09/2022
Monitoring Drug Safety in Pregnancy with Scan Statistics: A Comparison of Two Study Designs 10/18/2022
Describing Prenatal Exposures and Evaluating Maternal and Infant Outcomes in Sentinel 09/13/2022
Novel Methods for Pregnancy Drug Safety Surveillance in the FDA Sentinel System 07/24/2022
Use of Real-World Data for Surveillance of Medications in Pregnancy 05/09/2022
CNODES Webinar: Surveillance of Adverse Infant Outcomes Following Maternal Medication Use During Pregnancy Using Tree-Based Scan Statistics 03/09/2022
Use of Multiple Sclerosis Drugs Among Pregnant Women with Live-Birth Deliveries: A Descriptive Analysis 10/20/2021
Making Medicaid Data More Accessible Through Common Data Models and FHIR APIs 09/24/2021
Use of a Mobile App to Capture Supplemental Health Information During Pregnancy: Implications for Clinical Research 08/23/2021
TreeScan in Pregnancy 07/14/2021
Pregnancy among Women with Heart Failure: A Descriptive Analysis 03/07/2021
COVID-19 Pregnancy Study Implementation 02/24/2021
Using Prenatal Tests to Estimate Pregnancy Start in Health Insurance Claims Data 12/15/2020
Sentinel Public Training on Maternal Health and Pregnancy 11/02/2020
A New Propensity Score Matched Analysis Tool for Pregnancy: Replicating A Study of Oral Clefts following Topiramate Use during the First Trimester of Pregnancy 10/29/2020
FDA Labeling Change: Parenteral Iron Products and Risk of Severe Adverse Reactions to Pregnant Women and their Fetuses 09/11/2020
Dolutegravir Use Among Women of Child-Bearing Potential and During Early Pregnancy 08/27/2019
Coding Trend Analyses: Diabetes Mellitus with Pregnancy 04/15/2019