Tracks pregnancy and baby outcomes in people who took Ultomiris
Observes pregnancies and babies after mothers take Ultomiris for rare blood disorders.
Plain-language title generated from the registry record
Registry title: Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Key facts
- Where
- Rome, ItalySee the site
Where in Italy
- RomeRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alexion Pharmaceuticals, Inc.
- Trial code
- NCT06312644
- Record updated
- 16 April 2026
- Original description
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.Read full original descriptionShow less
Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
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.
Inclusion: Female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified); Participant informed consent (written or e-consent per local regulations or ethics committee requirements) must be obtained prior to the participant's enrollment. If the participant is a minor, consent must be obtained from the parent or legal guardian, with assent from the minor (as locally appropriate); Willing to provide contact information for the participant; Willing to authorize HCP(s) to release maternal and infant medical information to the study, upon request, if applicable to current local regulations; Diagnosed with an indication for which Ultomiris is approved, based on HCP or medical records; Exposed to Ultomiris at any point during the defined exposure window based on HCP or medical record documentation. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester or timing of exposure [prior to conception as LMP+14 days, or during breastfeeding].); Use of Ultomiris per local product information (i.e., United States Prescribing Information [USPI] or summary of product characteristics [SmPC]).
Exclusion: Participants who are unable to provide consent or assent (as locally appropriate) (e.g., diagnosed with severe psychiatric conditions or severe intellectual disabilities) will be excluded from this study.