E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
EARLY INTRAUTERINE GROWTH RESTRICTION |
CRECIMIENTO INTRAUTERINO RESTRINGIDO PRECOZ |
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E.1.1.1 | Medical condition in easily understood language |
INTRAUTERINE GROWTH LOWER THAT WOULD CORRESPOND TO THE AGE OF THE FETUS |
CRECIMIENTO INTRAUTERINO MÁS LENTO DE LO QUE CORRESPONDERÍA A LA EDAD DEL FETO |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048488 |
E.1.2 | Term | Growth intrauterine retard |
E.1.2 | System Organ Class | 100000114573 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
TO DEMONSTRATE THE EFFICACY OF LOW MOLECULAR WEIGHT HEPARIN IN THE PROLONGATION OF GESTATION TIME IN PATIENTS DIAGNOSED WITH EARLY INTRAUTERINE GROWTH RESTRICTION (IGR) . |
Demostrar la eficacia de la heparina de bajo peso molecular en la prolongación del tiempo de gestación de las pacientes con diagnóstico de CIR precoz. |
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E.2.2 | Secondary objectives of the trial |
• Demonstrate the efficacy of low molecular weight heparin in reducing neonatal morbidity in pregnancies diagnosed with early IGR. • Demonstrate that low molecular weight heparin improves the pro-angiogenic and anti-inflammatory profile both at the maternal and placental levels in gestations diagnosed with early IGR. • Demonstrate the efficacy of low molecular weight heparin in reducing thrombotic and ischemic placental lesions. |
• Demostrar la eficacia de la heparina de bajo peso molecular en reducir la morbilidad neonatal en las gestaciones con diagnóstico de CIR precoz. • Demostrar que la heparina de bajo peso molecular mejora el perfil pro-angiogénico y anti-inflamatorio tanto a nivel materno como placentario en las gestaciones con diagnóstico de CIR precoz. • Demostrar la eficacia de la heparina de bajo peso molecular en reducir las lesiones placentarias trombóticas e isquémicas.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
• Mujeres mayores de 18 años. • Gestaciones únicas. • Diagnóstico de crecimiento intrauterino restringido placentario precoz (de acuerdo a la clasificación Delphi ): <32 semanas al diagnóstico + Doppler AU con flujo ausente/reverso o (peso fetal estimado < percentil 10 + Doppler AU pulsátil) o (peso fetal estimado < percentil 10 + Doppler arterias uterinas pulsátil). • Paciente que otorga consentimiento informado por escrito para participar en el estudio.
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E.4 | Principal 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). |
• Cromosopatías, alteraciones genéticas o malformaciones fetales. • Tratamiento al diagnóstico con heparinas de bajo peso molecular, anticoagulantes orales o ácido acetilsalicílico previo a la inclusión. • Antecedentes de trombocitopenia inducida por heparina. • Hemorragia activa o incremento del riesgo de sangrado debido a alteraciones de la hemostasia. • Trastorno grave de la función hepática o pancreática. • Lesiones orgánicas susceptibles de sangrar (p. ej., úlcera péptica activa, accidente cerebro vascular hemorrágico, aneurismas o neoplasias cerebrales).
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E.5 End points |
E.5.1 | Primary end point(s) |
Gestational age (weeks) at birth (dated by ultrasonography <14 weeks by measurement of caudal skull length) |
Edad (semanas) gestacional al parto (datada por ecografía <14 semanas mediante medición de la longitud cráneo caudal) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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 |
Retraso de crecimiento intrauterino: Peso neonatal inferior al percentil 10 de nuestra población + índice de pulsatilidad en la arteria umbilical durante el tercer trimestre (en dos ocasiones separadas>48h) superior al percentil 95 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
ÚLTIMA VISITA DEL ÚLTIMO PACIENTE |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 27 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 27 |