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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001905-33 | EudraCT Number |
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| Name | Class |
|---|---|
| Servicio de AsesorÃa a la Investigación y LogÃstica SL | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Treatment with low molecular weight Heparin. |
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| Control Group | Placebo Comparator | Treatment with Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low molecular weight heparin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 13 weeks maximum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Edurne Mazarico | Hospital Sant Joan de Deu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30355790 | Derived | Mazarico E, Peguero A, Camprubi M, Rovira C, Gomez Roig MD, Oros D, Ibanez-Burillo P, Schoorlemmer J, Masoller N, Tassies MD, Figueras F. Study protocol for a randomised controlled trial: treatment of early intrauterine growth restriction with low molecular weight heparin (TRACIP). BMJ Open. 2018 Oct 23;8(10):e020501. doi: 10.1136/bmjopen-2017-020501. |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
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A randomized, double-blind, two-parallel, placebo-controlled, phase III multicenter clinical trial.
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| Placebos | Drug | 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). |
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| 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). | 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. | 13 weeks maximum |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |