Obstetrics risk Assessment: Evaluation of selection criteria for vaccine research studies in pregnant women
| Autor: | Judith Absalon, Fernanda Tavares Da Silva, Christine E. Jones, Clare L. Cutland, Asma Khalil, Caroline E. Rouse, Flor M. Munoz, Azucena Bardají, Sonali Kochhar, Alisa Kachikis, Linda O. Eckert |
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| Přispěvatelé: | Public Health |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Context (language use) obstetric and neonatal risk factors Article inclusion criteria SDG 3 - Good Health and Well-being Pregnancy vaccine medicine Humans Medical history vaccine safety Intensive care medicine Vaccines exclusion criteria General Veterinary General Immunology and Microbiology business.industry Patient Selection Public Health Environmental and Occupational Health Pregnancy Outcome clinical trial medicine.disease Clinical trial Obstetrics Infectious Diseases Clinical research clinical research Maternal immunization Inclusion and exclusion criteria Molecular Medicine Gestation Female Pregnant Women Risk assessment business |
| Zdroj: | Vaccine Vaccine, 38(29), 4542-4547. Elsevier |
| ISSN: | 1873-2518 0264-410X |
| DOI: | 10.1016/j.vaccine.2020.05.022 |
| Popis: | Highlights • Critical Assessment for Choosing Exclusion Criteria in Vaccine Trials involving Pregnant women (85 characters) • Obstetric and maternal risk factors in pregnancy quantified based on review of published literature (88 characters) • Heat Map Matrix of Obstetric Exclusion Criteria based on Phase of Trial (62 characters) • Obstetric Risk Assessment facilitates inclusion criteria choice in maternal immunization trials (87 characters) Vaccines designed for use in pregnancy and vaccine trials specifically involving pregnant women are rapidly expanding. One of the key challenges in designing maternal immunization trials is that developing exclusion criteria requires understanding and quantifying the background risk for adverse pregnancy outcomes in the pregnancy being studied, which can occur independent of any intervention and be unrelated to vaccine administration. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project has developed and published case definitions and guidelines for data collection, analysis, and evaluation of maternal immunization safety in trials involving pregnant women. Complementing this work, we sought to understand how to best assess obstetric risk of adverse outcomes and differentiate it from the assessment of vaccine safety. Quantification of obstetric risk is based on prior and current obstetric, and maternal medical history. We developed a step-wise approach to evaluate and quantify obstetric and maternal risk factors in pregnancy based on review of published literature and guidelines, and critically assessed these factors in the context of designing inclusion and exclusion criteria for maternal vaccine studies. We anticipate this risk assessment evaluation may assist clinical trialists with study design decisions, including selection of exclusion criteria for vaccine trials involving pregnant women, consideration of sub-group classification, such as high or low risk subjects, or schedule considerations, such as preferred trimester of gestation for an intervention during pregnancy. Additionally, this tool may be utilized in data stratification at time of study analyses. |
| Databáze: | OpenAIRE |
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