Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
NCT Number: NCT07371520
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.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Shanghai, Shanghai Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: within 72 hours after birth
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
Hemoglobin Concentration in Peripheral Blood of Neonates
Time frame: 30 days
The peak concentration of serum bilirubin is more than the exchange criteria of same gestational age and day age group
Contact information is provided by the study sponsor or research team.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Other
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