background rates of adverse pregnancy outcomes for assessing the safety of maternal vaccine trials in sub-saharan africa背景的不良妊娠结局评估孕产妇的安全疫苗试验在撒哈拉以南非洲.pdf

Background Rates of Adverse Pregnancy Outcomes for Assessing the Safety of Maternal Vaccine Trials in Sub- Saharan Africa 1,2 1,2 3 2 Lauren A. V. Orenstein , Evan W. Orenstein , Ibrahima Teguete , Mamoudou Kodio , 2,4 2,4 4 Milagritos Tapia , Samba O. Sow , Myron M. Levine * ´ ´ 1 Emory University School of Medicine, Atlanta, Georgia, United States of America, 2 Centre pour le Developpement des Vaccins-Mali, Bamako, Mali, 3 Gabriel Toure Teaching Hospital, Department of Obstetrics and Gynecology, Bamako, Mali, 4 Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America Abstract Background: Maternal immunization has gained traction as a strategy to diminish maternal and young infant mortality attributable to infectious diseases. Background rates of adverse pregnancy outcomes are crucial to interpret results of clinical trials in Sub-Saharan Africa. Methods: We developed a mathematical model that calculates a clinical trial’s expected number of neonatal and maternal deaths at an interim safety assessment based on the person-time observed during different risk windows. This model was compared to crude multiplication of the maternal mortality ratio and neonatal mortality rate by the number of live births. Systematic reviews of severe acute maternal morbidity (SAMM), low birth weight (LBW), prematurity, and major congenital malformations (MCM) in Sub-Saharan African countr