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Pregnancy

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
Risk of Non-Cardiac Congenital Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis
Utilization of Ibrexafungerp in Pregnant Patients: A Descriptive Analysis
Preliminary Analysis of Drug Utilization Data to Inform the Development of the Pregnancy Safety Study Framework
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
Utilization of Products for the Development of the Pregnancy Safety Study Framework Among Mothers with Live-Birth Deliveries: A Descriptive Analysis
Bevacizumab and Other Cancer Medication Use in Pregnant Patients: A Descriptive Analysis
Congenital Malformations Observed in the Mother’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis
Congenital Malformations Observed in the Mother’s or Linked Infant’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis
Assessing Medical Product Safety During Pregnancy using Parameterizable Tools in the Sentinel Distributed Database
Monitoring Drug Safety in Pregnancy with Scan Statistics: A Comparison of Two Study Designs
Describing Prenatal Exposures and Evaluating Maternal and Infant Outcomes in Sentinel
Novel Methods for Pregnancy Drug Safety Surveillance in the FDA Sentinel System
Characterizing Pregnant Women With and Without Evidence of Heart Failure and Non-Pregnant Women With Heart Failure: A Propensity Score Matched Analysis
Use of Real-World Data for Surveillance of Medications in Pregnancy
CNODES Webinar: Surveillance of Adverse Infant Outcomes Following Maternal Medication Use During Pregnancy Using Tree-Based Scan Statistics
Use of Multiple Sclerosis Drugs Among Pregnant Women with Live-Birth Deliveries: A Descriptive Analysis
Making Medicaid Data More Accessible Through Common Data Models and FHIR APIs
Use of a Mobile App to Capture Supplemental Health Information During Pregnancy: Implications for Clinical Research
TreeScan in Pregnancy
Pregnancy among Women with Heart Failure: A Descriptive Analysis
COVID-19 Pregnancy Study Implementation
Using Prenatal Tests to Estimate Pregnancy Start in Health Insurance Claims Data
Risk of Cardiac Congenital Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis
Risk of Cardiac Congenital Malformations Following Armodafinil or Modafinil Use: A Descriptive Analysis
Sentinel Public Training on Maternal Health and Pregnancy
A New Propensity Score Matched Analysis Tool for Pregnancy: Replicating A Study of Oral Clefts following Topiramate Use during the First Trimester of Pregnancy
FDA Labeling Change: Parenteral Iron Products and Risk of Severe Adverse Reactions to Pregnant Women and their Fetuses
Dolutegravir Use Among Women of Child-Bearing Potential and During Early Pregnancy
Coding Trend Analyses: Diabetes Mellitus with Pregnancy