Intrauterine Growth Restriction
Conditions
Brief summary
TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.
Detailed description
TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN: RANDOMIZED CLINICAL TRIAL (TRACIP STUDY).
Interventions
DRUGLow 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).
DRUGPlacebos
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).
Sponsors
Servicio de Asesoría a la Investigación y Logística SL
Fundació Sant Joan de Déu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
A randomized, double-blind, two-parallel, placebo-controlled, phase III multicenter clinical trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of low molecular weight heparin in the prolongation of gestation. | 13 weeks maximum | Measured as gestational age (weeks) at birth (dated by ultrasonography \<14 weeks by measurement of caudal skull length). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of low molecular weight heparin in reducing neonatal morbidity | 13 weeks maximum | 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. |
| Demonstrate that low molecular weight heparin improves the pro-angiogenic and anti-inflammatory profile. | 13 weeks maximum | 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). |
| Efficacy of low molecular weight heparin in reducing thrombotic and ischemic placental lesions | 13 weeks maximum | 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. |
Countries
Spain
Outcome results
None listed