Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN), Erythroblastosis, Fetal
Conditions
Keywords
Hemolytic disease of the fetus and newborn (HDFN), Erythroblastosis, Fetal, Early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN), M281, Pregnant Women
Brief summary
The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN).
Detailed description
The outcomes of interest will be assessed from the information collected on the standard of care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.
Interventions
OTHERNo intervention
No investigational drugs will be administered as part of the study
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pregnant female participants must be ≥18 years of age with an estimated Gestational Age of ≥ 8 weeks; not currently pregnant with multiples (twins or more); and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT) | GA Week 32 through GA Week 37 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants at GA Week 24 Without an IUT | Week 24 |
| GA at First IUT | Up to approximately GA Week 37 |
| Number of IUTs Required | Up to approximately GA Week 37 |
| Percentage of Participants With Fetal Hydrops | Post-Birth through Age 3 Months |
| Percentage of Participants With Live Birth | Up to approximately GA Week 37 |
| Percentage of Neonates Requiring Exchange Transfusions | Post-Birth through Age 3 Months |
| Number of days of phototherapy required by neonate | Post-Birth through Age 3 Months |
| Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life | Post-Birth through Age 3 Months |
| Number of Simple Transfusions Required by Neonate in the First 3 Months of Life | Post-Birth through Age 3 Months |
| Percentage of Neonates Requiring Phototherapy | Post-Birth through Age 3 Months |
Countries
Australia, Belgium, Canada, Germany, Netherlands, Spain, Sweden, United Kingdom, United States
Outcome results
None listed