E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022819 |
E.1.2 | Term | Intrauterine growth retardation |
E.1.2 | System Organ Class | 100000004868 |
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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 |
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E.2.2 | Secondary objectives of the trial |
Føtale: Perinatal død Gestationsalder ved forløsning Sarnat score Neonatal indlæggelsestid Neonatale komplikationer Maternelle: Udvikling af hypertension Udvikling af præeklampsi Udvikling af HELLP syndrom Antepartum blødning Post partum blødning Udvikling af abruptio placentae
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Singleton gravid Intrauterin væksthæmning påvist ved ultralyd: Inklusion i uge 19-20: Påvirket Arteria Uterina flow (pulsatility index >-1,7 SD) +/- Z-score<-1,7 på abdominal- eller hoved-omfang Inklusion fra uge 21: Fosterskønnet 22 % mindre end forventet + evt. påvirket Arteria Uterina flow (pulsatility index >-1,7). Kan forstå og læse dansk |
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E.4 | Principal exclusion criteria |
Eksklusionskriterier: 1: Alder < 18 år 2: Prægravid vægt > 90 kg 3: Ikke i stand til at give informeret samtykke 4: Kronisk nyresygdom med creatinin over 150 mikromol/liter 5: Kronisk hypertension med blodtryk over 140/90 mmHg 6: Diabetes mellitus; type 1 eller type 2 7: Aktiv inflammatorisk tarmsygdom 8: Svær hjertesygdom (inklusiv mekanisk hjerteklap) 9 Alkohol- eller stofmisbrug 10: Kendt koagulationsdefekt (von Willebrand sygdom, trombocytopeni, bærer af hæmofili) 11: Behandling med vitamin K-antagonister 12: Kendt allergi over for lavmolekylært heparin 13: Tidligere heparin induceret trombocytopeni (HIT (type II)) 14: Klinisk betydende blødning indenfor den sidste måned 15: Kvinder, hvor der er indikation for profylakse med lavmolekylært heparin under graviditeten f.eks. tidligere tromboembolisk sygdom eller alvorlige trombofilier (antitrombin mangel, protein C mangel eller protein S mangel) 16: Kromosomanomali hos barnet 17: Svære misdannelser hos barnet 18: Kontraindikation for Innohep® 19: Gestationsalder mere end 32 uger
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E.5 End points |
E.5.1 | Primary end point(s) |
Det primære effektmål er forskel i fødselsvægt ved sammenligning af børn født af kvinder, der har fået enten Innohep® eller ingen behandling. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |