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

Dataset contains consent tracking information for participants enrolled in the prospective Safe Passage Study. All participants were approached for participation in the main study. Pregnant participants who consented to the main study and are able to be evaluated at the 20-24 week time window were eligible for randomization into the embedded study. One consent form was required with an addendum for those consented nto the embedded study. Data was collected at recruitment (6 weeks to delivery admission) and tracked in this dataset and follows the Annotated Main Consent Tracking Form.
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.