Observational Study on the Safety of Ultomiris Ravulizumab During Pregnancy and Breastfeeding Tracking Maternal and Infant Outcomes Up to One Year After Exposure

What this Trial Is About

This research aims to understand the safety of Ultomiris Ravulizumab when used during pregnancy and breastfeeding. It focuses on describing how often and what kinds of pregnancy complications and maternal health issues occur in participants exposed to Ultomiris. The study also looks at certain outcomes for the fetus, newborn, and infant up to one year old after exposure to Ultomiris either during pregnancy or through breastmilk. The study observes participants who have been exposed to Ultomiris at any time during the 40 weeks before conception, throughout pregnancy, or during breastfeeding up to 52 weeks after birth. It collects both past and ongoing data without introducing any new treatments, following participants to monitor health and development over time. Participants will provide medical information about their pregnancy and maternal health, as well as data about their infants health from in utero through the first year after birth. Researchers will review pregnancy and maternal complications up to four weeks after delivery and track fetal and infant outcomes for up to 52 weeks after birth to understand the effects of Ultomiris exposure. Consent and medical record authorization are required for participation.

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy