Clinical trial

Treatment of Intrauterine Growth Restriction With Low Molecular Heparin: Randomized Clinical Trial. Tratamiento Del Crecimiento Intrauterino Restringido Precoz Con Heparina de Bajo Peso Molecular: Ensayo clínico Aleatorizado.

NCT03324139

Name

FSJD-TRACIP-2017

Description

TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.

Trial arms

Trial start

2018-01-25

Estimated PCD

2022-04-30

Trial end

2023-02-19

Status

Completed

Phase

Early phase I

Treatment

Low molecular weight heparin

Patients included in this study group will receive 3,500 IU / 0.2 ml / day of Bemiparina sc, from inclusion to delivery (estimated median of 5-6 weeks, with a maximum of 13 weeks).

Arms:

Study Group

Other names:

heparin

Placebos

Patients included in this study group will placebo (same presentation as the active drug), from inclusion to delivery (estimated median of 5-6 weeks, with a maximum of 13 weeks).

Arms:

Control Group

Other names:

sodium chloride (0.9%)

Size

Primary endpoint

Efficacy of low molecular weight heparin in the prolongation of gestation.

13 weeks maximum

Eligibility criteria

Inclusion Criteria: * Women older than 18 years. * Unique gestations * Diagnosis of early placental intrauterine growth (according to Delphi classification): \<32 weeks at diagnosis + Doppler AU with absent / reverse flow or (estimated fetal weight \<10 percentile + pulsed Doppler ultrasonography) or (estimated fetal weight \<percentile 10 + pulsed uterine artery Doppler). * Patient giving written informed consent to participate in the study. Exclusion Criteria: * Chromosopathies, genetic alterations or fetal malformations. * Diagnostic treatment with low molecular weight heparins, oral anticoagulants or acetylsalicylic acid prior to inclusion. * History of heparin-induced thrombocytopenia. * Active hemorrhage or increased risk of bleeding due to changes in hemostasis. * Severe hepatic or pancreatic function disorder. * Organic lesions that may bleed (eg, active peptic ulcer, hemorrhagic stroke, aneurysms, or brain tumors).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, double-blind, two-parallel, placebo-controlled, phase III multicenter clinical trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

Updated at

2024-04-22

1 organization

2 products

1 indication

Organization

Fundació Sant Joan de Déu

Product

Low molecular weight heparin

Indication

Intrauterine Growth Restriction

Product

Placebos