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Global Observational Study on Hemolytic Disease of the Fetus and Newborn in Pregnant Women at Risk Tracking Pregnancy and Infant Outcomes with Standard Care
Led by Janssen Research & Development, LLC · Updated on 2026-07-31
175
Participants Needed
15
Research Sites
18 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying pregnant individuals at risk for hemolytic disease of the fetus and newborn HDFN, a condition where incompatible blood types between mother and baby cause rapid breakdown of fetal or newborn red blood cells. This observational study aims to evaluate the risk of anemia in fetuses and newborns receiving standard care, tracking outcomes from pregnancy through two years after birth. The study looks at complications such as fetal loss, transfusions, and neonatal death to better understand HDFNs impact. Participants receive standard medical care for HDFN as per local clinical practice without additional study treatments. Data collection occurs throughout pregnancy and continues for two years after birth for the baby. Participants will provide medical information and complete questionnaires at set times during follow-up. Data is gathered from medical centers that routinely treat HDFN to capture comprehensive clinical outcomes. During the study, researchers will collect detailed medical records, including clinical outcome assessments reported by patients or observers. They will measure outcomes such as fetal loss, intrauterine transfusions, hydrops fetalis, neonatal death, and disease severity. The study tracks pregnancies from conception through the neonatal period and continues monitoring infants up to two years. This long-term follow-up helps understand the course and effects of HDFN under standard care conditions.
CONDITIONS
Brief Title
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
Research Team
S
Study Contact
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