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LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention

RecruitingPhase 4Ages 18 Years - anyFemaleAlexandra Hospital, Athens, Greece
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 โ‰ฅ18 years * Willing and able to provide written informed consent * Adequate ability for follow-up (direct telephone communication, accessible residence) Exclusion Criteria: * Multiple pregnancy * Current permanent aspirin use for other medical indications * Serious congenital fetal abnormality detected on ultrasound * 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/ฮผL), active or recent significant bleeding, history of heparin-induced thrombocytopenia * Pre-existing severe renal failure (creatinine clearance \<30 mL/min) * Unable to provide informed consent * Low probability of adequate follow-up (residence in remote areas without telephone access, accommodation in temporary structures)
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What it tests

  • Aspirin
  • Tinzaparin
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Where

1 site
First Department of Obstetrics and Gynecology, Alexandra Hospital
Athens, Greece
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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