The overall goal of the existing R34 Planning Grant is to address considerations in the development of a longitudinal study of pregnant women and their offspring to evaluate typical brain development as well as the effects of maternal substance use during prenatal life on that brain development. Aim 2 of the existing R34 project is as follows: Test feasibility at each site to implement a common protocol developed in Aim 1 for neuroimaging, infant and early childhood growth and development, assessment of exposure, and recommendations for integration of emerging innovative technologies that will encompass the period from prenatal through the first 24 months of life.

With the onset of the SARS-CoV-2 pandemic in early 2020, significant challenges have emerged with respect to completion of Aim 2 and the future design of a Phase II study. There is an evolving, pervasive, and continuing health, social, and economic impact of the pandemic among the population of women of reproductive age in general, as well as the subset of individuals who have become infected. In fact, fear of infection and lack of knowledge about previous infection status could affect the largest segment of the population of pregnant or soon- to-be pregnant women in the U.S. This unusual and dramatic set of events is likely to negatively influence both the health of women who will go on to become pregnant and be eligible to enroll in a future Phase II study. In addition, these events could potentially impinge on the circumstances under which women and their families would be willing to engage in clinical research of this type.

In addition to exposure to the virus itself, increased levels of anxiety and stress (or exacerbations of pre-existing mental health conditions) associated with the pandemic may influence substance use by pregnant women. Furthermore, specific anxieties about the safety of conditions under which routine or exceptional medical visits can be conducted, as well as access to and delivery of appropriate treatments, could alter the health status of pregnant women and their children.

To help address the potential influence of some of these factors relative to our existing Aim 2, particularly in the pregnancy period and in the first few months of the newborn’s life, we will build on an existing and ongoing national pregnancy cohort study of women with a wide range of underlying health conditions. With additional measures, we will specifically address COVID- 19 symptoms, testing and antibody status as well as the behaviors of pregnant study participants in the presence of the pandemic. The supplemental project will support re-consent of currently enrolled women, antibody testing for 583 women at 1-2 time points in pregnancy, additional collection of COVID-19 symptoms and testing results, and analysis of data consistent with the expanded Aims below.