Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT07361679

LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention

Led by Alexandra Hospital, Athens, Greece · Updated on 2026-01-23

100

Participants Needed

1

Research Sites

232 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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/bcL), 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

First Department of Obstetrics and Gynecology, Alexandra Hospital

Athens, Attica, Greece, 11528

Actively Recruiting

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Research Team

D

Dimitrios Baroutis, MD, MSc, PhD(c)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention | DecenTrialz