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

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

Prenat Diagn

. 2021 Sep 22. doi: 10.1002/pd.6047. Online ahead of print. https://pubmed.ncbi.nlm.nih.gov/34550624/

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

Rebecca N Spencer 1 2Kurt Hecher 3Gill Norman 4 5Karel Marsal 6Jan Deprest 2 7Alan Flake 8Francesc Figueras 9 10Christoph Lees 11Steve Thornton 12Kathleen Beach 13Marcy Powell 14Fatima Crispi 9 10Anke Diemert 15Neil Marlow 16Donald M Peebles 2 17Magnus Westgren 18Helena Gardiner 19Eduard Gratacos 20 21Jana Brodszki 6Albert Batista 22Helen Turier 23Mehali Patel 24 25Beverley Power 26James Power 26Gillian Yaz 27Anna L David 2 17Affiliations expand

Abstract

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 Terminology (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 (MFAET) version 1.0. allows systematic consistent AE assessment in pregnancy trials to improve safety. This article is protected by copyright. All rights reserved.

Keywords: adverse event; clinical trial; fetal; maternal; neonatal; pregnancy; therapy.

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