| アブストラクト | INTRODUCTION: Considering the high prevalence of polypharmacy in pregnant women and the knowledge gap in the risk-benefit safety profile of their often-complex treatment plan, more research is needed to optimise prescribing. In this study, we aim to detect adverse and protective effect signals of exposure to individual and pairwise combinations of medications during pregnancy. METHODS AND ANALYSIS: Using a range of real-world data sources from the UK, we aim to conduct a pharmacovigilance study to assess the safety of medications prescribed during the preconception period (3 months prior to conception) and first trimester of pregnancy. Women aged between 15 and 49 years with a record of pregnancy within the Clinical Practice Research Datalink (CPRD) Pregnancy Register, the Welsh Secure Anonymised Information Linkage (SAIL), the Scottish Morbidity Record (SMR) data sets and the Northern Ireland Maternity System (NIMATS) will be included. A series of case control studies will be conducted to estimate measures of disproportionality, detecting signals of association between a range of pregnancy outcomes and exposure to individual and combinations of medications. A multidisciplinary expert team will be invited to a signal detection workshop. By employing a structured framework, signals will be transparently assessed by each member of the team using a questionnaire appraising the signals on aspects of temporality, selection, time and measurement-related biases and confounding by underlying disease or comedications. Through group discussion, the expert team will reach consensus on each of the medication exposure-outcome signal, thereby excluding spurious signals, leaving signals suggestive of causal associations for further evaluation. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Independent Scientific Advisory Committee, SAIL Information Governance Review Panel, University of St. Andrews Teaching and Research Ethics Committee and Office for Research Ethics Committees Northern Ireland (ORECNI) for access and use of CPRD, SAIL, SMR and NIMATS data, respectively. |
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| 投稿者 | Subramanian, Anuradhaa; Lee, Siang Ing; Hemali Sudasinghe, Sudasing Pathirannehelage Buddhika; Wambua, Steven; Phillips, Katherine; Singh, Megha; Azcoaga-Lorenzo, Amaya; Cockburn, Neil; Wang, Jingya; Fagbamigbe, Adeniyi; Usman, Muhammad; Damase-Michel, Christine; Yau, Christopher; Kent, Lisa; McCowan, Colin; OReilly, Dermot; Santorelli, Gillian; Hope, Holly; Kennedy, Jonathan; Mhereeg, Mohamed; Abel, Kathryn Mary; Eastwood, Kelly-Ann; Black, Mairead; Loane, Maria; Moss, Ngawai; Brophy, Sinead; Brocklehurst, Peter; Dolk, Helen; Nelson-Piercy, Catherine; Nirantharakumar, Krishnarajah |
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| 組織名 | Institute of Applied Health Research, University of Birmingham, Birmingham, UK.;Division of Population and Behavioural Sciences, University of Saint Andrews;School of Medicine, St. Andrews, Fife, UK.;Hospital Rey Juan Carlos. Research Network on Chronicity, Primary Care and Health;Promotion-RICAPPS (RICORS), Instituto de Investigacion Sanitaria Fundacion;Jimenez Diaz, Madrid, Spain.;Department of Epidemiology and Medical Statistics, University of Ibadan, Ibadan,;Nigeria.;Medical and Clinical Pharmacology, School of Medicine, Universite Toulouse III,;Toulouse, France.;Center for Epidemiology and Research in Population Health (CERPOP), INSERM,;Nuffield Department of Women's and Reproductive Health, University of Oxford,;Oxford, UK.;Centre for Public Health, Queen's University Belfast, Belfast, UK.;Born In Bradford, Bradford Institute for Health Research, Bradford, UK.;Centre for Women's Mental Health, Faculty of Biology Medicine & Health,;University of Manchester, Manchester, UK.;Data Science, Medical School, Swansea University, Swansea, UK.;Swansea University Medical School, Swansea, UK.;Manchester Mental Health & Social Care Trust, Manchester, UK.;University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.;Aberdeen Centre for Women's Health Research, School of Medicine, Medical Science;and Nutrition, University of Aberdeen, Aberdeen, UK.;The Institute of Nursing and Health Research, University of Ulster, Belfast, UK.;Queen Mary University of London, London, UK.;Guy's & St Thomas' Foundation Trust, London, UK.;Institute of Applied Health Research, University of Birmingham, Birmingham, UK;k.nirantharan@bham.ac.uk. |
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