Study of Pregnancy And Neonatal Health (SPAN)

Eunice Kennedy Shriver National Institute Of Child Health & Human Development

Investigators

Abstract

Recruitment is anticipated at eight clinical sites located in North Carolina, Utah, Alabama, Virginia, Pennsylvania, and Louisiana. We anticipate about 11,525 pregnant women with about 3825 of their male partners to be recruited. Data will be captured using the NICHD Clinical Trials Data Base and in collaboration with a data coordinating center (DCC). Protocol and data collection forms are finalized and IRB review is underway. A detailed manual of procedures for the study and a data safety monitoring plan for the trial component was finalized. Study forms were programmed into the Clinical Trials Data Base and a learning management system is being developed by the DCC to manage staff training. The COVID-19 pandemic has caused some delays but all study teams are now actively recruiting for the study.