[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620750":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":43,"locations":50,"responsibleParty":74,"collaborators":48,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":48,"enrollmentInfo":87,"targetDuration":48,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":101,"overallStatus":52,"whyStopped":48,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Alexandra Hospital, Athens, Greece","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aspirin Alone","ACTIVE_COMPARATOR","Participants receive aspirin 160 mg orally once daily before bedtime from enrollment (\\\u003C16 weeks gestation) until 36 weeks gestation.",[13],"Drug: Aspirin",{"label":15,"type":16,"description":17,"interventionNames":18},"Aspirin plus LMWH","EXPERIMENTAL","Participants receive aspirin 160 mg orally once daily before bedtime PLUS weight-adjusted tinzaparin subcutaneously once daily in the morning (4,500 Anti-Xa IU for weight ≤60 kg, 6,000 Anti-Xa IU for weight 60-90 kg, 8,000 Anti-Xa IU for weight \\>90 kg) from enrollment (\\\u003C16 weeks gestation) until 36 weeks gestation.",[13,19],"Drug: Tinzaparin",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Aspirin","Aspirin 160 mg orally once daily before bedtime. Duration: From enrollment (\\\u003C16 weeks gestation) until 36 weeks gestation.",[9,15],[27,28,29],"ASA","Low-dose aspirin","Acetylsalicylic acid",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Tinzaparin","Weight-adjusted tinzaparin administered subcutaneously once daily in the morning: 4,500 Anti-Xa IU\u002Fday for weight ≤60 kg, 6,000 Anti-Xa IU\u002Fday for weight 60-90 kg, and 8,000 Anti-Xa IU\u002Fday for weight \\>90 kg. Duration: From enrollment (\\\u003C16 weeks gestation) until 36 weeks gestation.",[15],[35,36,37],"Low molecular weight heparin","Innohep","LMWH",[39],{"name":40,"affiliation":41,"role":42},"Georgios Daskalakis, PhD","First Department of Obstetrics and Gynecology, Alexandra Hospital","STUDY_CHAIR",[44],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},"Dimitrios Baroutis, MD, MSc, PhD(c)","CONTACT","+306978275745",null,"dbaroutis@gmail.com",[51],{"facility":41,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Athens","Attica","11528","Greece","GR",{"type":59,"coordinates":60},"Point",[61,62],23.72784,37.98376,{"lat":62,"lon":61},[65,67,71,73],{"name":45,"role":46,"phone":66,"phoneExt":48,"email":49},"+30 6978275745",{"name":68,"role":46,"phone":69,"phoneExt":48,"email":70},"Georgios Daskalakis, MD, PhD","+30 6945235757","gdaskalakis@yahoo.com",{"name":68,"role":72,"phone":48,"phoneExt":48,"email":48},"PRINCIPAL_INVESTIGATOR",{"name":45,"role":72,"phone":48,"phoneExt":48,"email":48},{"type":72,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"Georgios Daskalakis","Professor of Obstetrics and Gynecology","100620750","phase-4-lda-and-lmwh-vs-lda-alone-in-high-risk-patients-for-preeclampsia-prevention-100620750",false,"NCT07361679","LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention","Combined Administration of Low Molecular Weight Heparin and Aspirin Versus Aspirin Alone in Gravidas at High Risk for Preeclampsia: A Randomized Controlled Trial","preGO","Inclusion Criteria:\n\n* Singleton pregnancy\n* High risk for preeclampsia (risk \\>1:150) based on FMF screening algorithm combining first-trimester ultrasound, biochemical markers, and medical history\n* Gestational age \\\u003C16 weeks at enrollment\n* Maternal age ≥18 years\n* Willing and able to provide written informed consent\n* Adequate ability for follow-up (direct telephone communication, accessible residence)\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Current permanent aspirin use for other medical indications\n* Serious congenital fetal abnormality detected on ultrasound\n* Contraindication to aspirin or low molecular weight heparin including: known hypersensitivity, active peptic ulcer disease, bleeding disorders or coagulopathy, severe thrombocytopenia (platelet count \\\u003C100,000\u002FμL), active or recent significant bleeding, history of heparin-induced thrombocytopenia\n* Pre-existing severe renal failure (creatinine clearance \\\u003C30 mL\u002Fmin)\n* Unable to provide informed consent\n* Low probability of adequate follow-up (residence in remote areas without telephone access, accommodation in temporary structures)","FEMALE","18 Years",{"count":88,"type":89},100,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","Preeclampsia is a major cause of maternal and perinatal morbidity and mortality worldwide. Low-dose aspirin started in the first trimester reduces the risk of preeclampsia in high-risk women. Low molecular weight heparin (LMWH) has shown potential benefits in addition to aspirin for preventing preeclampsia through its anticoagulant, anti-inflammatory, and endothelial protective effects. However, current evidence is limited and conflicting regarding the added value of LMWH to aspirin. This randomized controlled trial aims to evaluate the efficacy of combined aspirin and LMWH, compared to aspirin alone, for reducing the incidence of preeclampsia in high-risk gravidas.",[95,96,97,98,99,100],"Preeclampsia Severe","Toxemia Of Pregnancy","Preeclampsia","Pregnancy Complications","Hypertension, Pregnancy-Induced","Gestational Hypertension",[102,103,104,105,35,106,107,37,108],"preeclampsia","gestational hypertension","toxemia","Preeclampsia prevention","tinzaparin","High-risk pregnancy","Maternal-fetal medicine","2026-01-15",{"date":111,"type":112},"2026-01-23","ACTUAL",{"date":114,"type":112},"2023-01-18",{"date":116,"type":89},"2027-07-01",{"name":5,"class":6},1]