An observational study in Ultomiris-exposed Pregnant/ Postpartum, Pregnancy and Paroxysmal Nocturnal Hemoglobinuria (PNH), sponsored by Alexion Pharmaceuticals, Inc.. Recruiting at 7 sites in 7 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Alexion Pharmaceuticals, Inc. · Observational
The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.
This observational study will collect prospective and retrospective data in participants exposed to Ultomiris during pregnancy and/or breastfeeding to assess risk of maternal complications, adverse effects on the developing fetus, and adverse effects on the infant.
Participants exposed to Ultomiris at any point up to 40 weeks prior to conception (Last Menstrual Period +14 days) through pregnancy and/or breastfeeding through the first 52 weeks of the infant's life.
Exclusion Criteria:
Participants exposed to Ultomiris at any point during the 40 weeks prior to conception (LMP+14 days) or at any point during pregnancy or breastfeeding up to 52 weeks after birth.
Also known as: There is no interventional drug. Ultomiris treatment is an inclusion criterion.
Pregnancy Complications
Pregnancy outcomes
Time frame: Up to 4 weeks post-delivery
Maternal Complications
Maternal Complications may include pre-eclampsia, eclampsia, deep-vein thrombosis (DVT), pregnancy-induced hypertension, gestational diabetes, preterm labor, placenta previa, and postpartum hemorrhage
Time frame: Up to 4 weeks post-delivery
Fetal/Infant Outcomes
Fetal (in Utero)/infant (for Live Born Births) may include major congenital malformation (MCMs), full-term birth, preterm birth, low birth weight, size for gestational age, neonatal death, perinatal death, infant death, serious and severe infections of infants, infant hospitalization, growth delays, and abnormal postnatal growth and development
Time frame: In utero through 52 weeks of age after exposure to Ultomiris (in utero or via breastmilk)
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Alexion Pharmaceuticals, Inc.