The research question is: What is the risk of adverse pregnancy outcomes, including preterm birth, hypertensive disorders of pregnancy, and other maternal and neonatal/infant outcomes, following exposure to ABRYSVO between 32 weeks 0 days and 36 weeks 6 days of gestation in the CorEvitas RSV Vaccine Pregnancy Registry (RSV-PR)?
The primary study objective is to estimate the risk of (1) preterm birth and (2) hypertensive disorders of pregnancy following exposure to ABRYSVO between 32 weeks 0 days and 36 weeks 6 days of gestation.
The secondary study objective is to estimate the risk of the following other safety outcomes of interest following exposure to ABRYSVO between 32 weeks 0 days and 36 weeks 6 days of gestation:
(1) pregnancy-related outcomes: stillbirth, premature labor, premature rupture of membranes (PROM), preterm premature rupture of membranes (PPROM), cesarean delivery, prolonged maternal duration of hospital stay,
(2) maternal outcomes: thrombocytopenia, Guillain-Barré Syndrome (GBS), other immune-mediated demyelinating conditions, polyneuropathies, atrial fibrillation, maternal death, and
(3) neonatal/infant outcomes: small for gestational age (SGA), large for gestational age, low birth weight (LBW), admission to a neonatal intensive care unit (NICU), NICU duration of stay, mechanical ventilation in neonatal period, neonatal death, postnatal growth at 1 year of age.
The exploratory study objective is to describe the most frequently reported maternal adverse events (AEs) following exposure to ABRYSVO between 32 weeks 0 days and 36 weeks 6 days of gestation.