NCT07361679RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 21 Dec 2025
- Start date
- 18 Jan 2023
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Alexandra Hospital, Athens, Greece
- Diseases
- High blood pressure
- NCT number
- NCT07361679
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 18 Jan 2023 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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)
Other
- Multiple pregnancy
- Current permanent aspirin use for other medical indications
- Serious congenital fetal abnormality detected on ultrasound
- Unable to provide informed consent
- Low probability of adequate follow-up (residence in remote areas without telephone access, accommodation in temporary structures)
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Department of Obstetrics and Gynecology, Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.