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The safe passage study: design, methods, recruitment, and follow-up approach
Kimberly A Dukes1, Larry Burd, Amy J Elliott
1DM-STAT, Inc., Malden, MA.
Paediatric and Perinatal Epidemiology
|August 19, 2014
Summary
The Safe Passage Study investigates prenatal alcohol exposure's link to stillbirth and SIDS. It also explores the biological basis of related outcomes in mothers and infants.
Area of Science:
- Perinatal Health
- Maternal-Fetal Medicine
- Neurodevelopmental Disorders
Background:
- The Safe Passage Study is a large, prospective, multidisciplinary research initiative.
- It aims to investigate the association between prenatal alcohol exposure, sudden infant death syndrome (SIDS), and stillbirth.
- The study also seeks to determine the biological underpinnings of phenotypic outcomes from exposure, considering environmental and genetic modifiers.
Purpose of the Study:
- To examine the relationship between alcohol consumption during pregnancy and adverse pregnancy outcomes like SIDS and stillbirth.
- To elucidate the biological mechanisms contributing to fetal alcohol spectrum disorders (FASD) and other developmental issues in children exposed to alcohol prenatally.
- To identify genetic and environmental factors that may exacerbate the risks associated with prenatal alcohol exposure.
Main Methods:
- Interim analysis of 6004 enrolled women from high-risk regions (Northern Plains, US, and Cape Town, South Africa).
- Prospective, multidisciplinary study design with prenatal, delivery/newborn, and postnatal follow-up through 1 year post-delivery.
- High participant consent rates for biological sample collection (DNA, placental tissue) and autopsy procedures.
Main Results:
- High overall visit compliance (87%) and excellent pregnancy outcome ascertainment (98%).
- Low participant withdrawal rate (<2%) ensuring robust data integrity.
- Over 94% consent for DNA and placental tissue use, and 71% for autopsy participation.
Conclusions:
- The Safe Passage Study represents a pioneering multi-site effort integrating prospective exposure data with comprehensive biological information for SIDS and stillbirth research.
- The study's success hinges on strong community engagement and stringent adherence to protocols and procedures.
- This integrated approach provides a unique platform for understanding the complex interplay of factors affecting maternal and infant health outcomes related to prenatal alcohol exposure.
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