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
Alexandra Hospital, Athens, Greece
100 participants
Jan 18, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria7
- 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)
Interventions
Aspirin 160 mg orally once daily before bedtime. Duration: From enrollment (\<16 weeks gestation) until 36 weeks gestation.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07361679