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

Julie-Anne Quinn, Flor M. Munoz, Bernard Gonik, Lourdes Frau, Clare Cutland, Tamala Mallett-Moore, Aimee Kissou, Frederick Wittke, Manoj Das, Tony Nunes, Savia Pye, Wendy Watson, Ana Maria Alguacil Ramos, Jose F. Cordero, Wan Ting Huang, Sonali Kochhar, Jim Buttery, The Brighton Collaboration Preterm Birth Working Group

Research output: Contribution to journalArticleOtherpeer-review

157 Citations (Scopus)


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 confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and post-implementation programmes of immunisations in pregnancy.

Original languageEnglish
Pages (from-to)6047-6056
Number of pages10
Issue number49
Publication statusPublished - 1 Dec 2016


  • Adverse event
  • Antenatal
  • Case definition
  • Guidelines
  • Immunisation
  • Preterm birth

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