EGA Institute for Women's Health


Adverse Event Terminology

The development of new drugs for use in obstetrics is long overdue. Maternal and perinatal disease counts for approximately 7% of global disease, yet fewer than 5% of the number of drugs being developed to combat cardiovascular disease are designed to help new mothers and pregnant women.

Our research is developing new obstetric therapies. We have also worked with the Royal College of Obstetricians and Gynaecologists (RCOG) to suggest ways that barriers to finding new treatments could be overcome.

See the paper here - Developing New Pharmaceutical Treatments for Obstetric Conditions  

Developing Maternal and Fetal Adverse Event severity grading criteria

To assess the safety of a potential new therapy, researchers record any Adverse Events (AEs) which occur during clinical trials. To get the most detailed safety data these AEs are usually graded from 1 to 5. Standard criteria exist for grading hundreds of AEs, but these are inadequate and inconsistent for trials of maternal and fetal therapies.

The EVERREST International Adverse Event Consensus Group met for the first time in May 2015 to begin the process of developing standard maternal and fetal AE severity grading criteria. This group includes fetal therapy, obstetric, neonatal, and pharmaceutical industry experts from Europe and the United States. The first set of criteria were adopted by MedDRA, the Medical Dictionary of Regulatory Activities in their updated Version 19.0 in March 2016.

AE meeting