Journal article

Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety data

JA Quinn, FM Munoz, B Gonik, L Frau, C Cutland, T Mallett-Moore, A Kissou, F Wittke, M Das, T Nunes, S Pye, W Watson, AMA Ramos, JF Cordero, WT Huang, S Kochhar, J Buttery

Vaccine | ELSEVIER SCI LTD | Published : 2016

Abstract

Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidenc..

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University of Melbourne Researchers

Grants

Awarded by National Institute of Environmental Health Sciences


Funding Acknowledgements

The authors are grateful for the support and helpful comments provided by the Brighton Collaboration (Jan Bonhoeffer, Jorgen Bauwens) and the reference group (see https://brightoncollaboration.org/public/what-we-do/setting-standards/case-definitions/groups.html for reviewers), as well as other experts consulted as part of the process, including professor Euan Wallace. The authors are also grateful to the Brighton Collaboration Secretariat and to the members of the ISPE Special Interest Group in Vaccines (VAX SIG) for their review and constructive comments on this document. Finally, we would like to acknowledge the Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) project, funded by the Bill and Melinda Gates Foundation.