The safe passage study

Design, methods, recruitment, and follow-up approach

PASS Research Network

Research output: Contribution to journalArticle

30 Citations (Scopus)

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 tissueexceed 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.

Original languageEnglish (US)
Pages (from-to)455-465
Number of pages11
JournalPaediatric and Perinatal Epidemiology
Volume28
Issue number5
DOIs
StatePublished - 2014
Externally publishedYes

Fingerprint

Sudden Infant Death
Stillbirth
Mothers
Fetal Alcohol Spectrum Disorders
Pregnancy Outcome
South Africa
Drinking
Compliance
Autopsy
Alcohols
Newborn Infant
Prospective Studies
Pregnancy
DNA
Research

Keywords

  • Fetal alcohol spectrum disorders
  • PASS
  • Prenatal alcohol exposure
  • Safe Passage Study
  • Stillbirth
  • Study methodology
  • Sudden infant death syndrome

ASJC Scopus subject areas

  • Epidemiology
  • Pediatrics, Perinatology, and Child Health

Cite this

The safe passage study : Design, methods, recruitment, and follow-up approach. / PASS Research Network.

In: Paediatric and Perinatal Epidemiology, Vol. 28, No. 5, 2014, p. 455-465.

Research output: Contribution to journalArticle

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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 tissueexceed 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.",
keywords = "Fetal alcohol spectrum disorders, PASS, Prenatal alcohol exposure, Safe Passage Study, Stillbirth, Study methodology, Sudden infant death syndrome",
author = "{PASS Research Network} and Dukes, {Kimberly A.} and Larry Burd and Elliott, {Amy J.} and Fifer, {William P.} and Folkerth, {Rebecca D.} and Gary Hankins and Dale Hereld and Hoffman, {Howard J.} and Myers, {Michael M.} and Odendaal, {Hein J.} and Caroline Signore and Sullivan, {Lisa M.} and Marian Willinger and Colleen Wright and Kinney, {Hannah C.}",
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AU - PASS Research Network

AU - Dukes, Kimberly A.

AU - Burd, Larry

AU - Elliott, Amy J.

AU - Fifer, William P.

AU - Folkerth, Rebecca D.

AU - Hankins, Gary

AU - Hereld, Dale

AU - Hoffman, Howard J.

AU - Myers, Michael M.

AU - Odendaal, Hein J.

AU - Signore, Caroline

AU - Sullivan, Lisa M.

AU - Willinger, Marian

AU - Wright, Colleen

AU - Kinney, Hannah C.

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N2 - 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 tissueexceed 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.

AB - 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 tissueexceed 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.

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KW - Study methodology

KW - Sudden infant death syndrome

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