A global non-interventional registry study is underway to evaluate the risk of anemia in fetuses and neonates born to pregnant women at risk for hemolytic disease of the fetus and newborn (HDFN), the study details were published in clinicaltrials.gov.
HDFN is caused by maternal-fetal blood type incompatibility, leading to destruction of fetal red blood cells and resulting in potentially life-threatening anemia. . Despite advances in perinatal care, predicting outcomes remains challenging, especially since most current risk models are retrospective and limited to single-center experiences.
In this context, the authors aim to deepen the understanding of fetal and neonatal outcomes under current standards of care.This prospective study seeks to address these gaps by following a multinational cohort over time.
Learn more about HDFN symptoms and risks
The observational study plans to enroll 175 pregnant women with a history of immunization and evidence of fetal antigen positivity. Participants will not receive investigational treatments; instead, they will be monitored while receiving standard care at specialized centers in the U.S. and Italy. Data will be collected through routine clinical visits, medical record reviews, and standardized patient- and observer-reported outcome measures. Follow-up will continue until two years after delivery.
The primary endpoint is the percentage of pregnancies that do not result in fetal loss, intrauterine transfusion (IUT), hydrops fetalis (liquid accumulation), or neonatal death. Secondary outcomes include the number and severity of HDFN cases, the time to first IUT or hydrops diagnosis, and the neonatal morbidity index based on complications such as intraventricular hemorrhage or respiratory distress. The number of IUTs performed during pregnancy will also be documented.
The study classifies HDFN severity on a five-point scale, ranging from minimal symptoms requiring phototherapy to fatal outcomes. It will also assess modified neonatal morbidity and mortality indices to capture the full spectrum of disease impact in live-born infants.
This registry offers a valuable opportunity to collect comprehensive prospective data on HDFN outcomes across diverse clinical settings.
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