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| Name | Class |
|---|---|
| Xiamen Amoytop Biotech Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topefilgrastim 0.5mg Group | Experimental |
| |
| Topefilgrastim 1mg Group | Experimental |
| |
| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topefilgrastim Injection | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
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)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Wang | Contact | 13919302888 | ery_fwang@lzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fang Wang | Lanzhou University Second Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lanzhou University Second Hospital | Lanzhou | China |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Investigator-Initiated Trial (IIT)
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| Topefilgrastim Injection | Drug | Subjects will receive subcutaneous injection of 1 mg Topefilgrastim starting from Week 1 Day 1 (W1D1), with a frequency of once every two weeks, for at least 8 consecutive weeks. |
|
| 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 | including maternal/fetal or perinatal infants | From 11 weeks of pregnancy to 6 weeks postpartum |
| 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 |