Background Rates of Adverse Pregnancy Outcomes for Assessing the Safety of Maternal Vaccine Trials in Sub-Saharan Africa 英文参考文献.docVIP

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Background Rates of Adverse Pregnancy Outcomes for Assessing the Safety of Maternal Vaccine Trials in Sub-Saharan Africa 英文参考文献.doc

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Background Rates of Adverse Pregnancy Outcomes for Assessing the Safety of Maternal Vaccine Trials in Sub-Saharan Africa 英文参考文献

BackgroundRatesofAdversePregnancyOutcomesfor AssessingtheSafetyofMaternalVaccineTrialsinSub- SaharanAfrica LaurenA.V.Orenstein1,2,EvanW.Orenstein1,2,IbrahimaTeguete3,MamoudouKodio2, MilagritosTapia2,4,SambaO.Sow2,4,MyronM.Levine4* 1Emory University School of Medicine, Atlanta, Georgia, United States of America, 2Centre pour le De′veloppement des Vaccins-Mali, Bamako, Mali, 3Gabriel Toure′ TeachingHospital,DepartmentofObstetricsandGynecology,Bamako,Mali,4CenterforVaccineDevelopment,UniversityofMarylandSchoolofMedicine,Baltimore, Maryland,UnitedStatesofAmerica 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 clinicaltrialsinSub-SaharanAfrica. Methods:Wedevelopedamathematicalmodelthatcalculatesaclinicaltrial’sexpectednumberofneonatalandmaternal deathsataninterimsafetyassessmentbasedontheperson-timeobservedduringdifferentriskwindows.Thismodelwas comparedtocrudemultiplicationofthematernalmortalityratioandneonatalmortalityratebythenumberoflivebirths. Systematicreviewsofsevereacutematernalmorbidity(SAMM),lowbirthweight(LBW),prematurity,andmajorcongenital malformations(MCM)inSub-SaharanAfricancountrieswerealsoperformed. Findings:Accountingfortheperson-timeobservedduringdifferentriskperiodsyieldslower,moreconservativeestimates of expected maternal and neonatal deaths, particularly at an interim safety evaluation soon after a large number of deliveries.MedianincidenceofSAMMin16reportswas40.7(IQR:10.6–73.3)per1,000totalbirths,andthemostcommon causes were hemorrhage (34%), dystocia (22%), and severe hypertensive disorders of pregnancy (22%). Proportions of liveborn infants who were LBW (median 13.3%, IQR: 9.9–16.4) or premature (median 15.4%, IQR: 10.6–19.1) were similar acrossgeographicregion,studydesign,andinstitutionalsetting.ThemedianincidenceofMCMper1,000livebirthswas 14.4(IQR:5.5