MedTrace Logo

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

NCT07361679 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Preeclampsia Severe
  • Toxemia Of Pregnancy
  • Preeclampsia
  • Pregnancy Complications
  • Hypertension, Pregnancy-Induced
  • Gestational Hypertension

Interventions

DRUG

Aspirin

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

DRUG

Tinzaparin

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.

Sponsors & Collaborators

  • Alexandra Hospital, Athens, Greece

    lead OTHER

Principal Investigators

  • Georgios Daskalakis, PhD · First Department of Obstetrics and Gynecology, Alexandra Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2026-08-01
Completion
2027-07-01

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07361679 on ClinicalTrials.gov