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

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Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology
Prenatal Diagnosis ( IF 2.7 ) Pub Date : 2021-09-22 , DOI: 10.1002/pd.6047
Rebecca N Spencer _{1,

2} , Kurt Hecher ₃ , Gill Norman _{4,

5} , Karel Marsal ₆ , Jan Deprest _{2,

7} , Alan Flake ₈ , Francesc Figueras _{9,

10} , Christoph Lees ₁₁ , Steve Thornton ₁₂ , Kathleen Beach ₁₃ , Marcy Powell ₁₄ , Fatima Crispi _{9,

10} , Anke Diemert ₁₅ , Neil Marlow ₂ , Donald M Peebles _{2,

16} , Magnus Westgren ₁₇ , Helena Gardiner ₁₈ , Eduard Gratacos _{10,

19} , Jana Brodszki ₆ , Albert Batista ₉ , Helen Turier ₂₀ , Mehali Patel _{21,

22} , Beverley Power ₂₃ , James Power ₂₃ , Gillian Yaz ₂₄ , Anna L David _{2,

16}

Affiliation

School of Medicine, University of Leeds, Leeds, UK.
Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.
Department of Obstetrics and Fetal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Division of Nursing, Midwifery & Social Work, Faculty of Biology, Medicine and Health, School of Health Sciences, University of Manchester, Manchester, UK.
Antenatal Results and Choices Charity, UK.
Lund University, Lund, Sweden.
Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
Department of Surgery, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Institut D'Investigacions Biomèdiques August Pi ì Sunyer, Barcelona, Spain.
BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Ciínic and Hospital Sant Joan de Deu), University of Barcelona, Spain.
Queen Charlottes and Chelsea Hospital, Imperial College London, London, UK.
Queen Mary University of London, London, UK.
Global Health Unit, GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
Safety and Medical Governance, GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
Clinic for Obstetrics and Prenatal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
NIHR UCLH Biomedical Research Centre, London, UK.
Karolinska Institute, Stockholm, Sweden.
The Fetal Center, UTHealth McGovern Medical School, Houston, Texas, USA.
Center for Biomedical Research on rare Diseases (CIBERER), Institut D'Investigacions Biomèdiques August Pi ì Sunyer, Universitat de Barcelona, Barcelona, Spain.
Twins Trust Charity, Aldershot, UK.
Bliss Charity, London, UK.
Sands Charity, London, UK.
CDH UK: The Congenital Diaphragmatic Hernia Support Charity, King's Lynn, UK.
SHINE: Spina bifida, Hydrocephalus, Information, Networking, Equality Charity, Peterborough, UK.

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.

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