Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology

Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive framework to define and grade maternal and fetal AEs in pregnancy trials severely limits understanding risks in pregnant women. We created AE terminology to improve safety monitoring for developing pregnancy drugs, devices and interventions.Existing severity grading for pregnant AEs and definitions/indicators of 'severe' and 'life-threatening'...