Treatment of Intrauterine Growth Restriction With Low Molecular Heparin.

Fundació Sant Joan de Déu48 enrolled

Overview

TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.

TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN: RANDOMIZED CLINICAL TRIAL (TRACIP STUDY).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Intrauterine Growth Restriction

Interventions

Low molecular weight heparinDRUG

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).

PlacebosDRUG

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).

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, Spain

Outcomes

Primary Outcomes

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

Measured as gestational age (weeks) at birth (dated by ultrasonography \<14 weeks by measurement of caudal skull length).

Time frame: 13 weeks maximum

Secondary Outcomes

Efficacy of low molecular weight heparin in reducing neonatal morbidity

Measured as the presence of one or more of the following: Perinatal mortality (\> 22 weeks of gestation - \<28 days postpartum), Significant neonatal morbidity (convulsions, intraventricular haemorrhage\> grade III, periventricular leukomalacia, hypoxic-ischemic encephalopathy, abnormal electroencephalogram, necrotizing enterocolitis, acute renal failure (serum creatinine\> 1.5 mg / dL) or cardiac failure (requiring inotropic agents), Perinatal mortality (22 weeks to 28 postnatal days), Biomarkers.

Time frame: 13 weeks maximum

Demonstrate that low molecular weight heparin improves the pro-angiogenic and anti-inflammatory profile.

Measured as the presence of one or more of the following: mother blood biomarkers (sFlt and PlGF), biomerkers, umbilical cord blood biomarkers (TNF alfa, IL6, IFN gamma, FGF basic, VEGF and PlGF), mRNA in trophoblast.( IL6, INFg, TNF alfa, VEGFA, VEGFB, FGF2 y RQVEGF).

Time frame: 13 weeks maximum

Efficacy of low molecular weight heparin in reducing thrombotic and ischemic placental lesions

Measured as the presence of one or more of the following: Intrauterine growth retardation (Neonatal weight below the 10th percentile of our population + umbilical artery pulsatility index during the third trimester (on two separate occasions\> 48h) above the 95th percentile), Preeclampsia, Gestational age (weeks) at birth, Premature delivery before 34 weeks of gestation, Urgent cesarean section due to loss of fetal well-being, Neonatal weight, Neonatal acidosis (arterial pH \<7.10 + EB\> 12mEq / L), Days stay in the Neonatal Intensive Care Unit, mRNA in trophoblast.

Time frame: 13 weeks maximum

Data from ClinicalTrials.gov

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