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

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…

ClinicalTrials.gov IDNCT07361679

PhasePHASE4

Enrollment100

SponsorAlexandra Hospital, Athens, Greece

Age18 Years

SexFEMALE

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Conditions studied

Preeclampsia Severe, Toxemia Of Pregnancy, Preeclampsia, Pregnancy Complications, Hypertension, Pregnancy-Induced, Gestational Hypertension

About this study

Interventions

Drug: Aspirin — Aspirin 160 mg orally once daily before bedtime. Duration: From enrollment (\<16 weeks gestation) until 36 weeks gestation.
Drug: Tinzaparin — Weight-adjusted tinzaparin administered subcutaneously once daily in the morning: 4,500 Anti-Xa IU/day for weight ≤60 kg, 6,000 Anti-Xa IU/day for weight 60-90 kg, and 8,000 Anti-Xa IU/day for weight \>90 kg. Duration: From enrollment (\<16 weeks gestation) until 36 weeks gestation.

Primary outcomes

Incidence of Preeclampsia (From enrollment until delivery (up to 40 weeks gestation))

Eligibility information

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 ≥18 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/μL), 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)

Study locations

First Department of Obstetrics and Gynecology, Alexandra Hospital, Athens, Attica 11528 Greece

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.