Study of RSV Vaccine Use in Pregnant Individuals Assessing Risks of Preterm Birth and Hypertensive Disorders and Other Maternal and Infant Outcomes After Vaccination at 32-36 Weeks Gestation

What this Trial Is About

This research aims to understand the risk of adverse pregnancy outcomes following exposure to the Respiratory Syncytial Virus RSV vaccine during late pregnancy, specifically between 32 weeks, 0 days and 36 weeks, 6 days of gestation. The study focuses on estimating the risk of preterm birth and hypertensive disorders of pregnancy as the primary objectives. It also examines a range of secondary maternal, pregnancy-related, and neonatalinfant outcomes, including stillbirth, premature labor, cesarean delivery, maternal complications, and infant health measures up to 1 year of age. Participants are divided into two groups those who receive the RSV vaccine during the specified gestational period and those who do not receive the vaccine during pregnancy. The study collects data from both groups through the CorEvitas Respiratory Syncytial Virus Vaccine Pregnancy Registry. Information is gathered via healthcare providers and participants at set times during pregnancy, at delivery, and during infant follow-up to track health outcomes and adverse events. Throughout the study, participants will provide data on pregnancy progress, maternal health, and infant development up to one year after birth. Researchers will use this data to assess the frequency and risk of various outcomes, including preterm birth, hypertensive disorders, and other complications. Safety monitoring includes capturing maternal adverse events occurring within 42 days after vaccination. The study is observational and plans to enroll approximately 2,062 participants, following them from enrollment until infant age of one year, with data collection ending in 2030 and final analysis in 2031.

RSV Vaccine Pregnancy Registry