Topefilgrastim Injection in the Treatment of High-Risk Pregnant Patients With Preeclampsia

Inclusion criteria

• Voluntarily participate in the study, be able to understand, and sign the informed consent form.
• Aged 18 to 45 years (inclusive) at the time of signing the informed consent form.
• Assessed as high-risk for preeclampsia at gestational weeks 11-13, defined as either:

A risk value of ≥1/100 based on the simplified Fetal Medicine Foundation (FMF) model, OR A high-risk result from serum biomarker screening (sFlt-1, PLGF, sFlt-1/PLGF ratio). (See Appendix for details)

• Gestational weeks 11-13 at enrollment.
• Singleton intrauterine pregnancy (confirmed by transvaginal or transabdominal ultrasound).

Exclusion criteria

• History of psychiatric disorder not adequately controlled by medication.
• Unexplained vaginal bleeding at screening.
• Known uterine malformation.
• Evidence of positive serology for HIV, HBV (HBsAg positive), HCV (anti-HCV antibody positive), or syphilis.
• Known proliferative retinopathy.
• Presence of severe organic disease or any other condition that, in the judgment of the investigator, makes the subject unsuitable for study participation.
• Planned or current use of medications with potential drug-drug interactions with human granulocyte colony-stimulating factor (G-CSF) analogs, such as lithium.
• Known allergy to rhG-CSF products or their components, or allergy to recombinant human proteins/peptides derived from E. coli.