Tdap vaccination during pregnancy and risk of chorioamnionitis and related infant outcomes. 

 -  2023 
<br/><br/> CONCLUSIONS AND RELEVANCE: Tdap vaccine exposure during pregnancy was not associated with chorioamnionitis, preterm birth, or adverse infant outcomes. ICD-10 codes for chorioamnionitis lack specificity for clinical chorioamnionitis and should be a recognized limitation when interpreting results. Copyright © 2023. Published by Elsevier Ltd.  INTRODUCTION: An increased risk of chorioamnionitis in people receiving tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine during pregnancy has been reported. The importance of this association is unclear as additional study has not demonstrated increased adverse infant outcomes associated with Tdap vaccination in pregnancy.  METHODS: We conducted a retrospective observational cohort study of pregnant people ages 15-49 years with singleton pregnancies ending in live birth who were members of 8 Vaccine Safety Datalink (VSD) sites during October 2016-September 2018. We used a time-dependent covariate Cox model with stabilized inverse probability weights applied to evaluate associations between Tdap vaccination during pregnancy and chorioamnionitis and preterm birth outcomes. We used Poisson regression with robust variance with stabilized inverse probability weights applied to evaluate the association of Tdap vaccination with adverse infant outcomes. We performed medical record reviews on a random sample of patients with ICD-10-CM-diagnosed chorioamnionitis to determine positive predictive values (PPV) of coded chorioamnionitisfor "probable clinical chorioamnionitis," "possible clinical chorioamnionitis," or "histologic chorioamnionitis."  RESULTS: We included 118,211 pregnant people; 103,258 (87%) received Tdap vaccine during pregnancy; 8098 (7%) were diagnosed with chorioamnionitis. The adjusted hazard ratio for chorioamnionitis in the Tdap vaccine-exposed group compared to unexposed was 0.96 (95% CI 0.90-1.03). There was no association between Tdap vaccine and preterm birth or adverse infant outcomes associated with chorioamnionitis. Chart reviews were performed for 528 pregnant people with chorioamnionitis. The PPV for clinical (probable or possible clinical chorioamnionitis) was 48% and 59% for histologic chorioamnionitis. The PPV for the combined outcome of clinical or histologic chorioamnionitis was 81%. 
<br/><br/><br/>English 
<br/><br/><label>ISSN: </label>0264-410X 
<br/><br/><label>Standard No.: </label>10.1016/j.vaccine.2023.04.043 [doi] S0264-410X(23)00457-7 [pii] 
<br/><br/><label>Subjects--Topical Terms: </label><br/>*Chorioamnionitis<br/>*Diphtheria-Tetanus-acellular Pertussis Vaccines<br/>*Premature Birth<br/>*Tetanus<br/>*Whooping Cough<br/>Chorioamnionitis/ci [Chemically Induced]<br/>Chorioamnionitis/ep [Epidemiology]<br/>Diphtheria-Tetanus-acellular Pertussis Vaccines/ae [Adverse Effects]<br/>Female<br/>Humans<br/>Infant<br/>Infant, Newborn<br/>Premature Birth/ci [Chemically Induced]<br/>Premature Birth/et [Etiology]<br/>Retrospective Studies<br/>Tetanus/pc [Prevention & Control]<br/>Toxoids<br/>Vaccination/ae [Adverse Effects]<br/>Vaccination/mt [Methods]<br/>Whooping Cough/pc [Prevention & Control]--Automated
<br/><br/><label>Subjects--Geographic Terms: </label><br/>MedStar Washington Hospital Center
<br/><br/><label>Index Terms--Occupation: </label><br/>Ambulatory Perinatology
<br/><br/><label>Index Terms--Function: </label><br/>Journal Article<br/>Observational Study