Serial Monitoring and Hyperimmunoglobulin versus Standard of Care to Prevent Congenital Cytomegalovirus Infection: A Phase III Randomized Trial

Serial Monitoring and Hyperimmunoglobulin versus Standard of Care to Prevent Congenital Cytomegalovirus Infection: A Phase III Randomized Trial

Introduction: Nonrandomized studies support the potential of cytomegalovirus hyperimmunoglobulin (CMV-HyperIg) in preventing maternofetal CMV transmission, but prospective interventional studies show equivocal results. We pre­sent a prospective phase-III international randomized open-label trial on...

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Veröffentlicht in:Fetal diagnosis and therapy 2021-10, Vol.48 (8), p.611-623
Hauptverfasser: Devlieger, Roland, Buxmann, Horst, Nigro, Giovanni, Enders, Martin, Jückstock, Julia, Siklós, Pal, Wartenberg-Demand, Andrea, Schüttrumpf, Jörg, Schütze, Joachim, Rippel, Natascha, Herbold, Marlis, Niemann, Gabriele, Friese, Klaus
Format: Artikel
Sprache:eng
Schlagworte:
Care and treatment
Cytomegalovirus infections
Diagnosis
Disease transmission
Diseases
Health aspects
Infants (Newborn)
Pregnant women
Prevention
Research Article
Risk factors
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Zusammenfassung:Introduction: Nonrandomized studies support the potential of cytomegalovirus hyperimmunoglobulin (CMV-HyperIg) in preventing maternofetal CMV transmission, but prospective interventional studies show equivocal results. We pre­sent a prospective phase-III international randomized open-label trial on the potential effect of CMV-HyperIg following serial monitoring of CMV serostatus. Methods: CMV-seronegative pregnant women (gestational age [GA]
ISSN:1015-3837
1421-9964
DOI:10.1159/000518508