Observational studyThe Journal of clinical endocrinology and metabolism2026
Maternal TSH-receptor antibodies predict fetal/neonatal hyperthyroidism in pregnancies with a history of Graves disease.
Observational study in The Journal of clinical endocrinology and metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
contextTransplacental transfer of thyrotropin receptor antibodies (TRAbs) during pregnancy may cause fetal/neonatal thyroid dysfunction. Current guidelines recommend a universal TRAb titer threshold, irrespective of gestational age or assay platform. However, evidence supporting trimester-specific and assay-specific thresholds is lacking.
objectiveThis work aimed to determine whether trimester-specific TRAb levels predict fetal/neonatal thyroid dysfunction and to establish assay-specific cutoff values for clinical risk stratification.
methodsIn this prospective, multicenter, observational cohort study (2010-2023), maternal TRAb titers were measured using the TRAK human assay on the BRAHMS Kryptor Compact Plus analyzer. Settings were tertiary and secondary care centers (n = 44) across the Netherlands. Patients included women with a history of (n = 500) or active (n = 178) Graves disease. Main outcome measures included biochemically confirmed fetal/neonatal hyperthyroidism or hypothyroidism.
resultsTrimester-specific TRAb titer thresholds predicted risk with high accuracy. In women with a history of Graves disease (n = 500), trimester-specific cutoffs of 25-, 19-, and 6-fold the upper limit of normal (ULN) showed a negative predictive value of 100%. In women with active Graves (n = 178), cutoffs of 10-, 12-, and 10-fold the ULN showed sensitivities of 89%, 86%, and 83%. Neonatal hyperthyroidism occurred despite low or declining maternal TRAb levels in mothers treated with antithyroid drugs.
conclusionTrimester-specific TRAb thresholds were higher than the universal ULN multipliers commonly applied in clinical practice, and differed by gestational age and disease status. Application of a single ULN-based threshold titer across different TRAb assays may result in misclassification (ie, overestimation of fetal and neonatal Graves disease) and consequently in unnecessary and resource-intensive fetal surveillance. This indicates that TRAb thresholds are assay specific and require platform-specific clinical validation, even when assays are calibrated against a common international standard.
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