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LMWH for Treatment of Early Fetal Growth Restriction (HepaGrowth)

Study acronym: HepaGrowth
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 13, 2025 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Secondary endpoints: 12 to 11v5
  2. Enrollment target: 120 to 12v4 Show 7 more changesShow less
    • Primary completion date: Dec 30, 2024 to Jul 30, 2026
    • Primary endpoints: 2 to 1
    • Study completion date: Jul 30, 2025 to Dec 30, 2026
    • Start date: Jul 6, 2023 to Jul 18, 2022
    • Eligibility criteria expanded, about 57 words
    • Secondary endpoints expanded, about 75 words
    • Study description shortened, about 39 words
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Oct 1, 2021 to Jul 6, 2023
    • Eligibility criteria expanded, about 113 words
    • Site contact updated
    v3
  4. Start date: Jun 1, 2021 to Oct 1, 2021v2 Show 4 more changesShow less
    • Primary completion date: Sep 30, 2024 to Dec 30, 2024
    • Study completion date: Apr 30, 2025 to Jul 30, 2025
    • Interventions: placebo (Other), subcutaneous Enoxaparin (Drug) to standard of care (Other), subcutaneous Enoxaparin (Drug)
    • Study description shortened, about 4 words
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04762992
Lead Sponsor Centro Hospitalar de Lisboa Central
Collaborators: NOVA Medical School
Conditions
(from sponsor)		 Fetal Growth Retardation, Prematurity, Pre-Eclampsia
Related terms Fetal Growth Retardation, Pre-Eclampsia, Premature Birth
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov