[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622539":3},{"organization":4,"outcomesModule":7,"designInfo":80,"detailedDescription":11,"studyPopulation":11,"armGroups":87,"interventions":99,"overallOfficials":108,"centralContacts":112,"locations":117,"responsibleParty":130,"collaborators":133,"id":137,"slug":11,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":11,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":11,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":156,"whyStopped":11,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Lanzhou University Second Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"soluble fms-like tyrosine kinase-1(sFlt-1)",null,"Gestational weeks 11-13；15-17；24-28",{"measure":14,"description":11,"timeFrame":12},"placental growth factor(PLGF)",{"measure":16,"description":11,"timeFrame":12},"sFlt-1\u002FPLGF ratio",[18,21,23,25,27,29,31,33,35,37,39,41,43,45,47,49,51,53,55,57,59,61,63,65,67,69,71,74,76,78],{"measure":19,"description":11,"timeFrame":20},"Incidence of preeclampsia","From 11 weeks of pregnancy to 6 weeks postpartum",{"measure":22,"description":11,"timeFrame":20},"Incidence of early-onset preeclampsia",{"measure":24,"description":11,"timeFrame":20},"Incidence of PE-associated Preterm Delivery",{"measure":26,"description":11,"timeFrame":20},"Miscarriage rate",{"measure":28,"description":11,"timeFrame":20},"Preterm birth rate",{"measure":30,"description":11,"timeFrame":20},"Gestational age at delivery",{"measure":32,"description":11,"timeFrame":20},"Neonatal birth weight",{"measure":34,"description":11,"timeFrame":20},"Incidence of small for gestational age (SGA) neonates",{"measure":36,"description":11,"timeFrame":20},"Admission rate to the neonatal ward",{"measure":38,"description":11,"timeFrame":20},"NICU admission rate",{"measure":40,"description":11,"timeFrame":20},"Adverse Events (AEs)",{"measure":42,"description":11,"timeFrame":20},"Serious Adverse Events (SAEs)",{"measure":44,"description":11,"timeFrame":20},"Frequency of Adverse Events",{"measure":46,"description":11,"timeFrame":20},"Frequency of Serious Adverse Events",{"measure":48,"description":11,"timeFrame":20},"Severity of Adverse Events",{"measure":50,"description":11,"timeFrame":20},"Severity of Serious Adverse Events",{"measure":52,"description":11,"timeFrame":20},"Fetal Death",{"measure":54,"description":11,"timeFrame":20},"Perinatal Death",{"measure":56,"description":11,"timeFrame":20},"Incidence of congenital malformations",{"measure":58,"description":11,"timeFrame":20},"Body Temperature",{"measure":60,"description":11,"timeFrame":20},"Pulse",{"measure":62,"description":11,"timeFrame":20},"Respiratory Rate",{"measure":64,"description":11,"timeFrame":20},"Blood Pressure",{"measure":66,"description":11,"timeFrame":20},"Height",{"measure":68,"description":11,"timeFrame":20},"Weight",{"measure":70,"description":11,"timeFrame":20},"Number of Participants with Abnormal Laboratory Parameters Findings",{"measure":72,"description":73,"timeFrame":20},"Number of subjects with clinically significant abnormal findings in radiological examinations","including maternal\u002Ffetal or perinatal infants",{"measure":75,"description":11,"timeFrame":12},"Resistance Index (RI) of Uterine Spiral Arteries",{"measure":77,"description":11,"timeFrame":12},"Pulsatility Index (PI) of Uterine Arteries",{"measure":79,"description":11,"timeFrame":12},"Systolic to Diastolic Ratio (S\u002FD ratio) of Uterine Spiral Arteries",{"allocation":81,"interventionModel":82,"interventionModelDescription":83,"primaryPurpose":84,"observationalModel":11,"timePerspective":11,"maskingInfo":85},"NON_RANDOMIZED","PARALLEL","Investigator-Initiated Trial (IIT)","TREATMENT",{"masking":86,"maskingDescription":11,"whoMasked":11},"NONE",[88,93,96],{"label":89,"type":90,"description":11,"interventionNames":91},"Topefilgrastim 0.5mg Group","EXPERIMENTAL",[92],"Drug: Topefilgrastim Injection",{"label":94,"type":90,"description":11,"interventionNames":95},"Topefilgrastim 1mg Group",[92],{"label":97,"type":98,"description":11,"interventionNames":11},"Control Group","NO_INTERVENTION",[100,105],{"type":101,"name":102,"description":103,"armGroupLabels":104,"otherNames":11},"DRUG","Topefilgrastim 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.",[89],{"type":101,"name":102,"description":106,"armGroupLabels":107,"otherNames":11},"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.",[94],[109],{"name":110,"affiliation":5,"role":111},"Fang Wang","PRINCIPAL_INVESTIGATOR",[113],{"name":110,"role":114,"phone":115,"phoneExt":11,"email":116},"CONTACT","13919302888","ery_fwang@lzu.edu.cn",[118],{"facility":5,"status":11,"city":119,"state":11,"zip":11,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":128},"Lanzhou","China","CN",{"type":123,"coordinates":124},"Point",[125,126],103.83987,36.05701,{"lat":126,"lon":125},[129],{"name":110,"role":114,"phone":11,"phoneExt":11,"email":11},{"type":131,"investigatorFullName":110,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Chief physician",[134],{"name":135,"class":136},"Xiamen Amoytop Biotech Co., Ltd.","INDUSTRY","100622539",false,"NCT07384936","Topefilgrastim Injection in the Treatment of High-Risk Pregnant Patients With Preeclampsia","A Prospective, Controlled Study to Assess the Preliminary Efficacy and Safety of Topefilgrastim Injection in High-Risk Pregnant Patients With Preeclampsia.","Inclusion Criteria:\n\n* Voluntarily participate in the study, be able to understand, and sign the informed consent form.\n* Aged 18 to 45 years (inclusive) at the time of signing the informed consent form.\n* Assessed as high-risk for preeclampsia at gestational weeks 11-13, defined as either:\n\nA risk value of ≥1\u002F100 based on the simplified Fetal Medicine Foundation (FMF) model, OR A high-risk result from serum biomarker screening (sFlt-1, PLGF, sFlt-1\u002FPLGF ratio). (See Appendix for details)\n\n* Gestational weeks 11-13 at enrollment.\n* Singleton intrauterine pregnancy (confirmed by transvaginal or transabdominal ultrasound).\n\nExclusion Criteria:\n\n* History of psychiatric disorder not adequately controlled by medication.\n* Unexplained vaginal bleeding at screening.\n* Known uterine malformation.\n* Evidence of positive serology for HIV, HBV (HBsAg positive), HCV (anti-HCV antibody positive), or syphilis.\n* Known proliferative retinopathy.\n* Presence of severe organic disease or any other condition that, in the judgment of the investigator, makes the subject unsuitable for study participation.\n* Planned or current use of medications with potential drug-drug interactions with human granulocyte colony-stimulating factor (G-CSF) analogs, such as lithium.\n* Known allergy to rhG-CSF products or their components, or allergy to recombinant human proteins\u002Fpeptides derived from E. coli.","FEMALE","18 Years","45 Years",{"count":147,"type":148},100,"ESTIMATED","INTERVENTIONAL",[151],"NA","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\u002Fbiweekly group, the Topefilgrastim 1mg\u002Fbiweekly 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.",[154],"Preeclampsia",[154,102],"NOT_YET_RECRUITING","2026-01-26",{"date":159,"type":160},"2026-02-03","ACTUAL",{"date":162,"type":148},"2026-01-31",{"date":164,"type":148},"2027-12",{"name":110,"class":6},1]