The BRIUMVI™ Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between BRIUMVI™ exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
The outcomes of interest include major congenital malformations (MCMs; primary outcome), minor congenital malformations, gestational hypertension, pre-eclampsia, eclampsia, gestational diabetes, spontaneous abortions (SAB), stillbirths, elective terminations, small for gestational age (SGA), preterm births, postnatal growth deficiency, infant developmental delays, infant serious or opportunistic infections, and infant hospitalizations.
Pregnancy outcomes will be assessed throughout pregnancy, with data collection occurring at enrollment, the end of the second trimester, and pregnancy outcome. Infant outcomes will be assessed throughout the infant’s first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery.
Enrolled pregnant individuals and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable, will serve as data reporters to the registry. The study is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs.
Only data that are documented in patients’ medical records during the course of medical care will be collected. No additional laboratory tests or HCP assessments will be required as part of this
registry.