NCT07361679 LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention
| NCT ID | NCT07361679 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Alexandra Hospital, Athens, Greece |
| Condition | Preeclampsia Severe |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-01-18 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2023-01-18 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Georgios Daskalakis, PhD
STUDY CHAIR
First Department of Obstetrics and Gynecology, Alexandra Hospital
Frequently Asked Questions
Who can join the NCT07361679 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia Severe. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07361679 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07361679 currently recruiting?
Yes, NCT07361679 is actively recruiting participants. Contact the research team at dbaroutis@gmail.com for enrollment information.
Where is the NCT07361679 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT07361679 clinical trial?
NCT07361679 is sponsored by Alexandra Hospital, Athens, Greece. The principal investigator is Georgios Daskalakis, PhD at First Department of Obstetrics and Gynecology, Alexandra Hospital. The trial plans to enroll 100 participants.