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LMWH for Treatment of Early Fetal Growth Restriction (HepaGrowth)

NCT04762992 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-08-13

No results posted yet for this study

Summary

Early fetal growth restriction (FGR) is associated with considerable fetal and neonatal morbimortality. 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.

Conditions

  • Fetal Growth Retardation
  • Prematurity
  • Pre-Eclampsia

Interventions

DRUG

subcutaneous Enoxaparin

Enoxaparin subcutaneous injections (40 mg, 4000 IU daily) starting immediately after the diagnosis of FGR, and until 36 weeks of gestation or 12 hours before delivery, whichever comes first.

OTHER

standard of care

Obsteric standard of care.

Sponsors & Collaborators

  • NOVA Medical School

    collaborator OTHER

  • Centro Hospitalar de Lisboa Central

    lead OTHER

Principal Investigators

  • Fátima Serrano, MD, PhD · Centro Hospitalar Universitário de Lisboa Central

  • Catarina Palma-dos-Reis, MD, MSc · Centro Hospitalar Universitário de Lisboa Central

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2026-07-30
Completion
2026-12-30

Countries

  • Portugal

Study Locations

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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 NCT04762992 on ClinicalTrials.gov