title: The safe passage study: design, methods, recruitment, and follow-up approach.
abstract: BACKGROUND
  The Safe Passage Study is a large, prospective, multidisciplinary study designed to (1) investigate the association between prenatal alcohol exposure, sudden infant death syndrome (SIDS), and stillbirth, and (2) determine the biological basis of the spectrum of phenotypic outcomes from exposure, as modified by environmental and genetic factors that increase the risk of stillbirth, SIDS, and in surviving children, fetal alcohol spectrum disorders.
  
  
  METHODS
  The results provided are based on an interim assessment of 6004 women enrolled, out of the 12,000 projected, from the Northern Plains, US, and Cape Town, South Africa, areas known to be of high risk for maternal drinking during pregnancy. Research objectives, study design, and descriptive statistics, including consent, recruitment, and retention information, are provided.
  
  
  RESULTS
  Overall visit compliance is 87%, and includes prenatal, delivery/newborn, and postnatal contacts through 1 year post-delivery. Pregnancy outcome ascertainment is 98% prior to medical chart review; less than 2% of women withdraw. Consent for the use of DNA and placental tissue exceed 94%, and consent to participate in the autopsy portion of the study is 71%.
  
  
  CONCLUSIONS
  The Safe Passage Study is the first multi-site study of SIDS and stillbirth to integrate prospectively collected exposure information with multidisciplinary biological information in the same maternal and fetal/infant dyad using a common protocol. Essential components of the study design and its success are close ties to the community and rigorous systems and processes to ensure compliance with the study protocol and procedures.
authors.affiliation: DM-STAT, Inc., Malden, MA.
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Dukes
authors.forename: Larry
authors.initials: L
authors.lastname: Burd
authors.forename: Amy J
authors.initials: AJ
authors.lastname: Elliott
authors.forename: William P
authors.initials: WP
authors.lastname: Fifer
authors.forename: Rebecca D
authors.initials: RD
authors.lastname: Folkerth
authors.forename: Gary D V
authors.initials: GD
authors.lastname: Hankins
authors.forename: Dale
authors.initials: D
authors.lastname: Hereld
authors.forename: Howard J
authors.initials: HJ
authors.lastname: Hoffman
authors.forename: Michael M
authors.initials: MM
authors.lastname: Myers
authors.forename: Hein J
authors.initials: HJ
authors.lastname: Odendaal
authors.forename: Caroline
authors.initials: C
authors.lastname: Signore
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Sullivan
authors.forename: Marian
authors.initials: M
authors.lastname: Willinger
authors.forename: Colleen
authors.initials: C
authors.lastname: Wright
authors.forename: Hannah C
authors.initials: HC
authors.lastname: Kinney
mesh_terms: D000428:Alcohol Drinking / Q000453:epidemiology*; D005260:Female; D063647:Fetal Alcohol Spectrum Disorders / Q000453:epidemiology*; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D011247:Pregnancy; D011446:Prospective Studies; D012307:Risk Factors; D013019:South Africa / Q000453:epidemiology; D050497:Stillbirth / Q000453:epidemiology*; D013398:Sudden Infant Death / Q000453:epidemiology*; D014481:United States / Q000453:epidemiology
keywords: PASS; Safe Passage Study; fetal alcohol spectrum disorders; prenatal alcohol exposure; stillbirth; study methodology; sudden infant death syndrome