ArticlePregnancy (Hoboken, N.J.)2026
Characterization of the clinical course of early-onset severe hemolytic disease of the fetus and newborn.
Article in Pregnancy (Hoboken, N.J.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03755128 (A Multicenter, Prospective Observational Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn), which is not on this map. Not yet cited in PubMed.
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A Multicenter, Prospective Observational Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn
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21 authors.
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Abstract
Introduction: Severe fetal anemia developing at ≤24 weeks gestational age (GA) in pregnancies complicated by early-onset severe hemolytic disease of the fetus and newborn (EOS-HDFN) is managed by intrauterine erythrocyte transfusions (IUTs). Evidence of off-label intravenous immunoglobulin (IVIG) for preventing/reducing fetal hydrops, fetal anemia, and IUT(s) remains limited to retrospective studies and case series. The prospective, global, multicenter, observational CLARITY study characterized standard-of-care management and outcomes for high-risk pregnancies complicated by EOS-HDFN and their offspring at expert referral centers. Methods: CLARITY enrolled individuals with singleton pregnancies at ≥8 weeks GA and high risk for EOS-HDFN, defined by prior severe fetal anemia, fetal hydrops, or stillbirth at ≤24 weeks GA with indicative fetal/placental HDFN pathology, and current titers ≥32 anti-Rhesus D (RhD) or ≥4 anti-Kell with a confirmed antigen-positive fetus. Results: Of 15 pregnant participants, two (13%) achieved the primary endpoint of a live birth at ≥32 weeks GA without IUT, indicating the absence of clinically relevant fetal anemia and low disease burden. Fourteen (93%) pregnancies resulted in a live birth (median GA, 36 Conclusion: Outcomes of this prospective study of high-risk EOS-HDFN pregnant participants and their offspring are consistent with previous retrospective studies, indicating a high risk of early IUT, neonatal transfusions, and fetal/neonatal morbidity and mortality. The results underscore the unmet medical need for effective treatments for EOS-HDFN. Trial registration: ClinicalTrials.gov Identifier: NCT03755128.
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