This study adopted a single-center, prospective, observational study design. A consecutive cohort of pregnant and postpartum women who met the inclusion criteria was recruited from Shanghai First People's Hospital between January 2026 and December 2028. Quantitative hemorrhage detection was performed using residual clinical blood samples, and the diagnostic value of this detection for hemolytic disease of the newborn (HDN) was analyzed.
Study Type
OBSERVATIONAL
Enrollment
100
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Hemolytic Disease of the Newborn(HDN)
All the following criteria must have been met for a diagnosis of HDN: (1) Blood group incompatibility between the mother and newborn; (2) hyperbilirubinemia with a positive direct antiglobulin test (DAT) result or hyperbilirubinemia with a negative DAT result and a positive elution testing result with high suspicion of a hemolytic condition such as anemia and/or reticulocytosis.
Time frame: within 72 hours after birth
Anemia: hemoglobin
Hemoglobin Concentration in Peripheral Blood of Neonates
Time frame: within 72 hours after birth
Incidence of severe hyperbilirubinemia
The peak concentration of serum bilirubin is more than the exchange criteria of same gestational age and day age group
Time frame: 30 days
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