Application of Quantitative Hemorrhage Detection in Fetomaternal Hemorrhage Syndrome for the Diagnosis of Hemolytic Disease of the Newborn
Condition(s) studied
Study summary
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.
Eligibility
Primary outcome measure(s)
- Hemolytic Disease of the Newborn(HDN) — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality |
More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07371520 on ClinicalTrials.gov ↗ ← All trials in China