title: Evaluation of preterm births and birth defects in liveborn infants of US military women who received smallpox vaccine.
abstract: BACKGROUND
  Women serving in the US military have some unique occupational exposures, including exposure to vaccinations that are rarely required in civilian professions. When vaccinations are inadvertently given during pregnancy, such exposures raise special concerns. These analyses address health outcomes, particularly preterm births and birth defects, among infants who appear to have been exposed to maternal smallpox vaccination in pregnancy.
  
  
  METHODS
  This retrospective cohort study included 31,420 infants born to active-duty military women during 2003-2004. We used Department of Defense databases to define maternal vaccination and infant health outcomes. Multivariable regression models were developed to describe associations between maternal smallpox vaccination and preterm births and birth defects in liveborn infants.
  
  
  RESULTS
  There were 7,735 infants identified as born to women ever vaccinated against smallpox, and 672 infants born to women vaccinated in the first trimester of pregnancy. In multivariable modeling, maternal smallpox vaccination in pregnancy was not associated with preterm or extreme preterm delivery. Maternal smallpox vaccination in the first trimester of pregnancy was not significantly associated with overall birth defects (OR 1.40; 95% CI: 0.94, 2.07), or any of seven specific defects individually modeled.
  
  
  CONCLUSIONS
  Results may be reassuring that smallpox vaccine, when inadvertently administered to pregnant women, is not associated with preterm delivery or birth defects in liveborn infants.
authors.affiliation: US Department of Defense Center for Deployment Health Research, Naval Health Research Center, San Diego, California 92106, USA.
authors.forename: Margaret A K
authors.initials: MA
authors.lastname: Ryan
authors.forename: Gia R
authors.initials: GR
authors.lastname: Gumbs
authors.forename: Ava Marie S
authors.initials: AM
authors.lastname: Conlin
authors.forename: Carter J
authors.initials: CJ
authors.lastname: Sevick
authors.forename: Isabel G
authors.initials: IG
authors.lastname: Jacobson
authors.forename: Katherine J
authors.initials: KJ
authors.lastname: Snell
authors.forename: Christina N
authors.initials: CN
authors.lastname: Spooner
authors.forename: Tyler C
authors.initials: TC
authors.lastname: Smith
mesh_terms: D000328:Adult; D000013:Congenital Abnormalities / Q000453:epidemiology*; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D016015:Logistic Models; D008889:Military Personnel / Q000706:statistics & numerical data*; D016017:Odds Ratio; D011159:Population Surveillance; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D047928:Premature Birth / Q000453:epidemiology*; D012900:Smallpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D014611:Vaccination / Q000009:adverse effects*; D014615:Vaccinia / Q000517:prevention & control*; D014930:Women
chemical_list: D012900:Smallpox Vaccine