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

作者：Julie-Anne Quinn, Flor M. Muñoz, Bernard Gonik, Lourdes Frau, Clare Cutland, Tamala Mallett Moore, Aimée Sankaye-Lagom Kissou, Frederick Wittke, Manoja Kumar Das, Tony Nunes, Savia Pye, Wendy K. Watson, Ana-Maria Alguacil Ramos, José F. Cordero, Wan‐Ting Huang, Sonali Kochhar, Jim P Buttery · 发表于：Vaccine · 年份：2016 · DOI：10.1016/j.vaccine.2016.03.045 · 被引用次数：506 · 研究领域：Preterm Birth and Chorioamnionitis、Neonatal Respiratory Health Research、Pregnancy and preeclampsia studies

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.