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

Rebecca N. Spencer; Kurt Hecher; Gill Norman; Karel Marsal; Jan Deprest; Alan Flake; Francesc Figueras; Christoph Lees; Steve Thornton; Kathleen Beach; Marcy Powell; Fatima Crispi; Anke Diemert; Neil Marlow; Donald M. Peebles; Magnus Westgren; Helena Gardiner; Eduard Gratacos; Jana Brodszki; Albert Batista; Helen Turier; Mehali Patel; Beverley Power; James Power; Gillian Yaz; Anna L. David

doi:10.1002/pd.6047

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

Rebecca N. Spencer, Kurt Hecher, Gill Norman, Karel Marsal, Jan Deprest, Alan Flake, Francesc Figueras, Christoph Lees, Steve Thornton, Kathleen Beach, Marcy Powell, Fatima Crispi, Anke Diemert, Neil Marlow, Donald M. Peebles, Magnus Westgren, Helena Gardiner, Eduard Gratacos, Jana Brodszki, Albert BatistaHelen Turier, Mehali Patel, Beverley Power, James Power, Gillian Yaz, Anna L. David

Nursing & Midwifery

Research output: Contribution to journal › Article › peer-review

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 (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.

Original language	English
Journal	Prenatal diagnosis
Early online date	22 Sept 2021
DOIs	https://doi.org/10.1002/pd.6047
Publication status	Published - 12 Oct 2021

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10.1002/pd.6047Licence: CC BY

https://onlinelibrary.wiley.com/doi/10.1002/pd.6047

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Spencer, R. N., Hecher, K., Norman, G., Marsal, K., Deprest, J., Flake, A., Figueras, F., Lees, C., Thornton, S., Beach, K., Powell, M., Crispi, F., Diemert, A., Marlow, N., Peebles, D. M., Westgren, M., Gardiner, H., Gratacos, E., Brodszki, J., ... David, A. L. (2021). Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. Prenatal diagnosis. https://doi.org/10.1002/pd.6047

@article{de0cc0e12dc94a179e098cb3b111b304,

title = "Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology",

abstract = "ObjectiveAdverse 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.MethodExisting severity grading for pregnant AEs and definitions/indicators of {\textquoteleft}severe{\textquoteright} and {\textquoteleft}life-threatening{\textquoteright} 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.ResultsFetal 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.ConclusionsThis Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.",

author = "Spencer, {Rebecca N.} and Kurt Hecher and Gill Norman and Karel Marsal and Jan Deprest and Alan Flake and Francesc Figueras and Christoph Lees and Steve Thornton and Kathleen Beach and Marcy Powell and Fatima Crispi and Anke Diemert and Neil Marlow and Peebles, {Donald M.} and Magnus Westgren and Helena Gardiner and Eduard Gratacos and Jana Brodszki and Albert Batista and Helen Turier and Mehali Patel and Beverley Power and James Power and Gillian Yaz and David, {Anna L.}",

year = "2021",

month = oct,

day = "12",

doi = "10.1002/pd.6047",

language = "English",

journal = "Prenatal diagnosis",

issn = "0197-3851",

publisher = "John Wiley & Sons Ltd",

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Spencer, RN, Hecher, K, Norman, G, Marsal, K, Deprest, J, Flake, A, Figueras, F, Lees, C, Thornton, S, Beach, K, Powell, M, Crispi, F, Diemert, A, Marlow, N, Peebles, DM, Westgren, M, Gardiner, H, Gratacos, E, Brodszki, J, Batista, A, Turier, H, Patel, M, Power, B, Power, J, Yaz, G & David, AL 2021, 'Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology', Prenatal diagnosis. https://doi.org/10.1002/pd.6047

TY - JOUR

T1 - Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology

AU - Spencer, Rebecca N.

AU - Hecher, Kurt

AU - Norman, Gill

AU - Marsal, Karel

AU - Deprest, Jan

AU - Flake, Alan

AU - Figueras, Francesc

AU - Lees, Christoph

AU - Thornton, Steve

AU - Beach, Kathleen

AU - Powell, Marcy

AU - Crispi, Fatima

AU - Diemert, Anke

AU - Marlow, Neil

AU - Peebles, Donald M.

AU - Westgren, Magnus

AU - Gardiner, Helena

AU - Gratacos, Eduard

AU - Brodszki, Jana

AU - Batista, Albert

AU - Turier, Helen

AU - Patel, Mehali

AU - Power, Beverley

AU - Power, James

AU - Yaz, Gillian

AU - David, Anna L.

PY - 2021/10/12

Y1 - 2021/10/12

N2 - ObjectiveAdverse 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.MethodExisting 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.ResultsFetal 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.ConclusionsThis Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.

AB - ObjectiveAdverse 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.MethodExisting 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.ResultsFetal 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.ConclusionsThis Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.

U2 - 10.1002/pd.6047

DO - 10.1002/pd.6047

M3 - Article

SN - 0197-3851

JO - Prenatal diagnosis

JF - Prenatal diagnosis

ER -

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

Abstract

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