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Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology
Author(s) -
Spencer Rebecca N.,
Hecher Kurt,
Norman Gill,
Marsal Karel,
Deprest Jan,
Flake Alan,
Figueras Francesc,
Lees Christoph,
Thornton Steve,
Beach Kathleen,
Powell Marcy,
Crispi Fatima,
Diemert Anke,
Marlow Neil,
Peebles Donald M.,
Westgren Magnus,
Gardiner Helena,
Gratacos Eduard,
Brodszki Jana,
Batista Albert,
Turier Helen,
Patel Mehali,
Power Beverley,
Power James,
Yaz Gillian,
David Anna L.
Publication year - 2022
Publication title -
prenatal diagnosis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.956
H-Index - 97
eISSN - 1097-0223
pISSN - 0197-3851
DOI - 10.1002/pd.6047
Subject(s) - medicine , meddra , grading (engineering) , adverse effect , terminology , pregnancy , pharmacovigilance , delphi method , obstetrics , cardiotocography , common terminology criteria for adverse events , intensive care medicine , fetus , pediatrics , computer science , linguistics , philosophy , civil engineering , artificial intelligence , biology , engineering , genetics
Objective 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. Method Existing severity grading for pregnant AEs and definitions/indicators of ‘severe’ and ‘life‐threatening’ conditions relevant to maternal and fetal clinical trials were identified through a literature search. An international multidisciplinary group identified and filled gaps in definitions and severity grading using Medical Dictionary for Regulatory Activities (MedDRA) terms and severity grading criteria based on Common Terminology Criteria for Adverse Event (CTCAE) generic structure. The draft criteria underwent two rounds of a modified Delphi process with international fetal therapy, obstetric, neonatal, industry experts, patients and patient representatives. Results Fetal AEs were defined as being diagnosable in utero with potential to harm the fetus, and were integrated into MedDRA. AE severity was graded independently for the pregnant woman and her fetus. Maternal ( n = 12) and fetal ( n = 19) AE definitions and severity grading criteria were developed and ratified by consensus. Conclusions This Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.