LMWH for Treatment of Early Fetal Growth Restriction (HepaGrowth)

• Status: Not yet recruiting
• Trial end date: 2025-07-30
• Target enrollment: 0
• Participant gender: Female

Summary

Early fetal growth restriction (FGR) is associated with considerable fetal and neonatal morbimortality (Miller et al. 2008, Nardozza et al. 2017). Placental thrombosis, infarcts and hypercoagulability are frequently seen in these pregnancies, suggesting a role for the activation of the coagulation cascade in the genesis of FGR. Patients will be randomized for low-molecular weight heparin or standard of care, and the outcomes of both arms (gestational age at delivery, gestational and fetal morbidity) will be compared.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Hospitalar de Lisboa Central
• Collaborator: NOVA CRU, NOVA Medical School
• Treatments: Enoxaparin

Criteria

Inclusion Criteria:

• viable singleton pregnancy

• early FGR diagnosed according to the 2016 consensus criteria

• early FGR confirmed by the research centre

Exclusion Criteria:

• diagnosed fetal chromosomal abnormalities;

• associated fetal morphological malformations;

• evidence of fetal infection (serological or after invasive testing);

• use of aspirin, LMWH or non-fractionated heparin (NFH) in the index pregnancy before randomization;

• known allergy to LMWH or NFH;

• hypersensitivity to porcine products;

• antecedents of heparin-induced thrombocytopenia;

• maternal thrombocytopenia (platelets < 100 000);

• antecedents of anticoagulant hemostatic disorder;

• diagnosed placental hematoma;

• diagnosed maternal diabetic retinopathy;

• bacterial endocarditis;

• high risk of bleeding (recent ophthalmological, spinal or brain surgery);

• previous hemorrhagic stroke;

• persistent high blood pressure (> 160/100 mmHg), despite optimal anti-hypertensive regimen;

• active ulcerative or angiodysplastic diseases;

• severe renal disease (eGFR <30mL/min)