Abstract
BACKGROUND: Pregnant people are vulnerable to more severe outcomes of COVID-19 compared with their non-pregnant counterparts. Research is needed to systematically test the degree to which COVID-19 during pregnancy increases the risk for adverse maternal, perinatal, and infant health and development outcomes and whether social determinants of health or psychological/psychosocial health outcomes confound or intensify the risk. This protocol paper describes a prospective cohort study using electronic health record (EHR) and patient-reported data from four large health systems in Pennsylvania to examine neighborhood, social, and health factors predicting COVID-19 and its severity, birth weight, gestational age, and vaccination among pregnant people to 12 months postpartum. METHODS: Our study will be conducted with two aims. Aim 1 will combine maternal and infant clinical data and neighborhood data from four health systems in Pennsylvania participating in a PCORI-supported clinical research network. The cohort will include all people who were pregnant between June 2019 and May 2025, along with linkage to their newborn delivery records. In Aim 2, a subset of pregnant people from the Aim 1 cohort will be recruited to participate in a series of surveys from pregnancy to one year postpartum. Survey instruments will be developed to collect patient-reported health and social information as well as patient-centered outcomes depicting whether and how the COVID-19 pandemic is impacting pregnant people and their newborns. Survey data will be collected during pregnancy and at one, six, and 12 months postpartum. Survey data will be linked with data from Aim 1 for analysis. RESULTS: Ethical approval has been obtained at all sites. Subcontracts and data use agreements have been established. EHR data across health systems are being collected and curated. Surveys have been developed and recruitment and retention procedures implemented. Recruitment for the survey aim of the study began in July 2023 and is ongoing. DISCUSSION: This study will advance multi-site research involving pregnant people across diverse communities in a time of public health crisis. Data from this study will provide additional evidence of the impact of the COVID-19 pandemic on pregnant people and their infants. Findings will help guide future clinical and public health practices in pandemics for pregnant people.