Eligibility in A Prospective Study on the Role of Prenatal Alcohol Exposure in SIDS and Stillbirth

Dataset contains a record of eligibility criteria met for every pregnant person who provided informed consent (participant assent for women between 16-18 years and parental consent (one signature) required for Northern Plains). This dataset records whether a participant satisfied all inclusion criteria and none of the exclusion criteria for the prospective study as defined in the study protocol. Dataset tracks all data collected from the Annotated Participant Eligibility form at the recruitment visit (6 weeks to delivery admission). Study Description The Safe Passage Study was 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. The study enrolled pregnant people from the Northern Plains, US, and Cape Town, South Africa, areas known to be of high risk for maternal drinking during pregnancy. Research visits occurred during prenatal, delivery/newborn, and postnatal periods through 1 year post-delivery. The Safe Passage Study was 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 were close ties to the community and rigorous systems and processes to ensure compliance with the study protocol and procedures. Study participants included pregnant people and infants recruited from the Northern Plains, USA and South Africa, areas selected to ensure an adequate number of pregnant women with high alcohol exposure yielding poor outcomes, SIDS, stillbirth or FASD.