Preeclampsia
Conditions
Keywords
Preeclampsia, Topefilgrastim Injection
Brief summary
This study is an open-label, prospective investigation designed to enroll 100 high-risk pregnant subjects with preeclampsia (PE). Participants will be allocated in a 2:2:1 ratio to one of three groups: the Topefilgrastim 0.5mg/biweekly group, the Topefilgrastim 1mg/biweekly group, or the control group, based on investigator judgment and patient preference. The overall study consists of three parts: a screening period, a treatment period, and a follow-up period.
Interventions
DRUGTopefilgrastim Injection
Subjects will receive subcutaneous injection of 0.5 mg Topefilgrastim starting from Week 1 Day 1 (W1D1), with a frequency of once every two weeks, for at least 8 consecutive weeks.
Sponsors
Fang Wang
Xiamen Amoytop Biotech Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Investigator-Initiated Trial (IIT)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| soluble fms-like tyrosine kinase-1(sFlt-1) | Gestational weeks 11-13；15-17；24-28 |
| placental growth factor(PLGF) | Gestational weeks 11-13；15-17；24-28 |
| sFlt-1/PLGF ratio | Gestational weeks 11-13；15-17；24-28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of preeclampsia | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Incidence of early-onset preeclampsia | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Incidence of PE-associated Preterm Delivery | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Miscarriage rate | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Preterm birth rate | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Gestational age at delivery | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Neonatal birth weight | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Incidence of small for gestational age (SGA) neonates | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Admission rate to the neonatal ward | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| NICU admission rate | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Adverse Events (AEs) | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Serious Adverse Events (SAEs) | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Frequency of Adverse Events | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Frequency of Serious Adverse Events | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Severity of Adverse Events | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Severity of Serious Adverse Events | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Fetal Death | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Perinatal Death | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Incidence of congenital malformations | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Body Temperature | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Pulse | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Respiratory Rate | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Blood Pressure | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Height | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Weight | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Number of Participants with Abnormal Laboratory Parameters Findings | From 11 weeks of pregnancy to 6 weeks postpartum | — |
| Number of subjects with clinically significant abnormal findings in radiological examinations | From 11 weeks of pregnancy to 6 weeks postpartum | including maternal/fetal or perinatal infants |
| Resistance Index (RI) of Uterine Spiral Arteries | Gestational weeks 11-13；15-17；24-28 | — |
| Pulsatility Index (PI) of Uterine Arteries | Gestational weeks 11-13；15-17；24-28 | — |
| Systolic to Diastolic Ratio (S/D ratio) of Uterine Spiral Arteries | Gestational weeks 11-13；15-17；24-28 | — |
Countries
China
Contacts
CONTACTFang Wang
PRINCIPAL_INVESTIGATORFang Wang
Lanzhou University Second Hospital
Outcome results
None listed