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Study on the Application of Quantitative Detection of Feto-Maternal Hemorrhage in the Diagnosis of Hemolytic Disease of the Newborn

Study on the Application of Quantitative Detection of Feto-Maternal Hemorrhage in the Diagnosis of Hemolytic Disease of the Newborn

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119509
Enrollment
Unknown
Registered
2026-02-28
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemolytic Disease of the Newborn

Interventions

Fetomaternal hemorrhage (FMH) values >= 0.5%
Fetomaternal hemorrhage (FMH) value < 0.5%:Quantitative Detection of Fetal Red Blood Cells in Maternal Blood (FMH)

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Gestational Age: Singleton pregnant women with gestational age >= 20 weeks. 2. Clinical High-Risk Factors (meeting at least one of the following criteria): (1) Traumatic Factors: Abdominal trauma (e.g., traffic accident, fall), intrauterine fetal version, amniocentesis, chorionic villus sampling (CVS). (2) Obstetric Complications: Placental abruption, placenta previa, preeclampsia, unexplained antenatal hemorrhage, post-interventional therapy for twin-twin transfusion syndrome (TTTS). 3. Fetal Abnormalities: Fetal growth restriction (FGR), unexplained abnormal fetal heart rate monitoring, fetal hydrops, fetal anemia (elevated middle cerebral artery peak systolic velocity (MCA-PSV) detected by Doppler ultrasound). 4. High-Risk Population with Maternal-Fetal Blood Group Incompatibility: Maternal-fetal ABO or Rh-negative blood group incompatibility; positive result of the first-trimester antenatal antibody screening in pregnant women.

Exclusion criteria

Exclusion criteria: 1. Pregnant women complicated with severe hematological diseases (e.g., coagulation disorders, immune thrombocytopenic purpura) or autoimmune diseases. 2. Newborns who withdrew treatment for non-study-related reasons or were lost to follow-up after birth, resulting in missing outcome data. 3. Termination of pregnancy due to various causes. 4. Failure to complete the analysis due to unqualified core clinical data (e.g., quantitative hemorrhage test results, bilirubin levels) or unsatisfactory specimens (hemolysis, insufficient volume).

Design outcomes

Primary

MeasureTime frame
Hemolytic Disease of the Newborn (HDN);

Secondary

MeasureTime frame
Neonatal Anemia Severity;Neonatal Jaundice Level;Long-term Neonatal Prognosis;

Countries

China

Contacts

Public ContactZhang Jun

Shanghai General Hospital

16618843657@163.com+86 21 36126361

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026