Pregnancy (Hoboken, N.J.) · 2026
Characterization of the clinical course of early-onset severe hemolytic disease of the fetus and newborn.
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Oepkes Dick, Moise Kenneth J, Lopriore Enrico, Tiblad Eleonor, Verweij E J T Joanne, Windrim Rory, Pandya Pranav, Silver Robert M, Emery Stephen P, Smoleniec John, Ocón-Hernández Olga, Morris Rachel K, Miller Russell S, Streisand James B, Harrison Diane D, Smith Valerie, Schwartz Lisa B, Tjoa May Lee, Ling Leona E, Saeed-Khawaja Shumyla, Komatsu Yosuke
Аннотация
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, 362/7 weeks; range, 314/7-380/7), including seven (50%) preterm births and 12 (86%) cesarean deliveries. Thirteen (87%) participants required IUTs (median IUTs/pregnancy, 4; range, 1-11), with median GA at first IUT of 240/7 weeks (range, 130/7-282/7). One (7%) fetal death occurred at 165/7 weeks, following early IUT (130/7 weeks) and serial IVIG treatment (131/7-146/7 weeks). IUT complications occurred in four (31%) pregnant participants who received IUTs. In an exploratory, post hoc analysis, eight (53%) pregnant participants received IVIG starting between 106⁄7 and 193⁄7 weeks (median administrations/pregnancy, 12.5; range, 1-20); IVIG-related complications were reported in three (38%), and two (25%) met the primary endpoint. Of 14 live-born neonates followed through 12 weeks of life, three (21%) received exchange transfusion(s), nine (64%) received simple transfusion(s) (one required both types of transfusions), while three (21%) required no transfusions (one required no IUTs during the pregnancy).
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.
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, 362/7 weeks; range, 314/7-380/7), including seven (50%) preterm births and 12 (86%) cesarean deliveries. Thirteen (87%) participants required IUTs (median IUTs/pregnancy, 4; range, 1-11), with median GA at first IUT of 240/7 weeks (range, 130/7-282/7). One (7%) fetal death occurred at 165/7 weeks, following early IUT (130/7 weeks) and serial IVIG treatment (131/7-146/7 weeks). IUT complications occurred in four (31%) pregnant participants who received IUTs. In an exploratory, post hoc analysis, eight (53%) pregnant participants received IVIG starting between 106⁄7 and 193⁄7 weeks (median administrations/pregnancy, 12.5; range, 1-20); IVIG-related complications were reported in three (38%), and two (25%) met the primary endpoint. Of 14 live-born neonates followed through 12 weeks of life, three (21%) received exchange transfusion(s), nine (64%) received simple transfusion(s) (one required both types of transfusions), while three (21%) required no transfusions (one required no IUTs during the pregnancy).
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.