LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention
Recruiting · NCT07361679 · Interventional (participants receive a specific treatment) · Lead sponsor: Alexandra Hospital, Athens, Greece
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
1 location listed.
- First Department of Obstetrics and Gynecology, Alexandra Hospital - Athens, Attica, Greece