Aspirin With or Without Tinzaparin to Prevent Preeclampsia in High-Risk Pregnancy
Tests adding tinzaparin to aspirin to prevent preeclampsia in high-risk pregnant women.
Plain-language title generated from the registry record
Registry title: LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention
Key facts
- Where
- Athens, GreeceSee the site
- Phase
- Phase 4
Where in Greece
- First Department of Obstetrics and Gynecology, Alexandra HospitalAthens, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alexandra Hospital, Athens, Greece
- Trial code
- NCT07361679
- Record updated
- 23 January 2026
- Original description
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.Read full original descriptionShow less
Combined Administration of Low Molecular Weight Heparin and Aspirin Versus Aspirin Alone in Gravidas at High Risk for Preeclampsia: A Randomized Controlled Trial
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.
Inclusion: Singleton pregnancy; High risk for preeclampsia (risk >1:150) based on FMF screening algorithm combining first-trimester ultrasound, biochemical markers, and medical history; Gestational age <16 weeks at enrollment; Maternal age ≥18 years; Willing and able to provide written informed consent; Adequate ability for follow-up (direct telephone communication, accessible residence).
Exclusion: Contraindication to aspirin or low molecular weight heparin including: known hypersensitivity, active peptic ulcer disease, bleeding disorders or coagulopathy, severe thrombocytopenia (platelet count <100,000/μL), active or recent significant bleeding, history of heparin-induced thrombocytopenia; Pre-existing severe renal failure (creatinine clearance <30 mL/min); Multiple pregnancy; Current permanent aspirin use for other medical indications; Serious congenital fetal abnormality detected on ultrasound; Unable to provide informed consent; Low probability of adequate follow-up (residence in remote areas without telephone access, accommodation in temporary structures).