RecruitingPhase 4NCT07361679

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


Sponsor

Alexandra Hospital, Athens, Greece

Enrollment

100 participants

Start Date

Jan 18, 2023

Study Type

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a blood-thinning injection (low molecular weight heparin, LMWH) to low-dose aspirin works better than aspirin alone at preventing preeclampsia (dangerously high blood pressure during pregnancy) in women identified as high-risk. **You may be eligible if...** - You are pregnant with one baby (singleton pregnancy) - You are less than 16 weeks pregnant - You are at high risk for preeclampsia based on a first-trimester screening test (risk greater than 1 in 150) - You are 18 or older and can be reached by phone for follow-up **You may NOT be eligible if...** - You are carrying more than one baby - You are already taking aspirin long-term for another condition - Your baby has a serious detected birth defect - You have a known allergy to aspirin or heparin - You have a bleeding disorder, active peptic ulcer, severe low platelets, or a history of heparin-induced blood problems - You have severe kidney failure - You live in a remote area without phone access Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAspirin

Aspirin 160 mg orally once daily before bedtime. Duration: From enrollment (\<16 weeks gestation) until 36 weeks gestation.

DRUGTinzaparin

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)

First Department of Obstetrics and Gynecology, Alexandra Hospital

Athens, Attica, Greece

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NCT07361679


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