An observational study in Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) and Erythroblastosis, Fetal, sponsored by Janssen Research & Development, LLC. Completed at 18 sites in 9 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Janssen Research & Development, LLC · Observational
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).
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.
Participants must have an obstetrical history of severe fetal anemia, hydrops, or stillbirth related to hemolytic disease of the fetus and newborn, have alloantibody titers for anti-D ≥32 or anti-Kell titers ≥4, and be currently pregnant with an antigen-positive fetus. Eligible women may enter the study at any time during the current pregnancy prior to delivery.
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.
Other: No intervention
No investigational drugs will be administered as part of the study
Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)
Time frame: GA Week 32 through GA Week 37
Percentage of Participants With Live Birth
Time frame: Up to approximately GA Week 37
Percentage of Participants at GA Week 24 Without an IUT
Time frame: Week 24
GA at First IUT
Time frame: Up to approximately GA Week 37
Number of IUTs Required
Time frame: Up to approximately GA Week 37
Percentage of Participants With Fetal Hydrops
Time frame: Post-Birth through Age 3 Months
Percentage of Neonates Requiring Phototherapy
Time frame: Post-Birth through Age 3 Months
Percentage of Neonates Requiring Exchange Transfusions
Time frame: Post-Birth through Age 3 Months
Number of days of phototherapy required by neonate
Time frame: Post-Birth through Age 3 Months
Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life
Time frame: Post-Birth through Age 3 Months
Number of Simple Transfusions Required by Neonate in the First 3 Months of Life
Time frame: Post-Birth through Age 3 Months
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Erythroblastosis, Fetal
Janssen Research & Development, LLC