E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intrauterine growth restriction (IUGR) |
Retard de croissance intrautérin (RCIU) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
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 | 10022819 |
E.1.2 | Term | Intrauterine growth retardation |
E.1.2 | System Organ Class | 100000004868 |
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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 | 10048489 |
E.1.2 | Term | Intrauterine growth retard |
E.1.2 | System Organ Class | 100000004868 |
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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 | 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 |
Evaluate the effectiveness of treatment with enoxaparin 4000 anti-Xa IU/day administred from the diagnosis of vascular IUGR up to 36 weeks of gestation, or delivery in reducing the number of newborns with a birth weight below the 10th percentile |
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E.2.2 | Secondary objectives of the trial |
To assess the impact of treatment with enoxaparin in constituted vascular IUGR on : - resistance parameters observed on fœtal doppler examinations - fœtal growth kinetics - major and minor neonatal parameters
To assess the safety of treatment with enoxaparin
To assess predictif factors to a birth weight below the 10th percentile |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient over 18 years at > 22 and 34 weeks of gestation (WG) with vascular IUGR defined by : - estimated fœtal weight below the 10th percentile - clinical and ultrasound findings suggesting pathologically impaired growth or diminished fœtal well-being - clinical and ultrasound findings suggesting placental insufficiency
Precise dating of pregnancy by ultrasound between 11 WG and 13 WE +6days Written informed consent |
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E.4 | Principal exclusion criteria |
- Multiple pregnancy or identified cause of IUGR other than vascular - Patient with an immediate indication for fœtal extraction - Women with a history of venous thromboembolism or already treated with an anticoagulant - Women with contraindication to enoxaparin treatment at prophylactic doses Patient refusing to participate or unable to consent Platelet count < 80,00 platelets/mm3 at the initial assessment Patient denying self injection |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of newborns with a birth weight below the 10th percentile according the AUDIPOG formula (http://www.audipog.net/courbes_morpho.php). This formula calculates the exact birth weight percentile from gestational age at birth, sex of newborn and birth weight |
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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) |
1- Resistance parameters are : 1a- doppler examination of uterine arteries : pulsatility index, presence of unilateral or bilateral notch 1b - Umbilical doppler : resistance index, presence of zero diastole or reverse flow 2- Calculation of growth kinetics : birth weight by ultrasound 3- Major neonatal parameters measured are : perinatal death, ischaemic encephalopathy, major intra- or perivcentricular bleeding (grade 3 or 4) 4- Minor neonatal parameters measured are : caesarean section for fœtal distress, cord arterial pH<7.1, Apgar score <7 at 5 minutes, change in neonatal intensive care 5- Potential toxicity of the treatment : major or minor maternal bleeding event, cutaneous intolerance reaction, Thrombocytopenia, spontaneous bone pain, spontaneous fracture |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary endpoints 1 and 2 : change between initial ultrasound and follow-up ultra-sound Secondary endpoints 3 and 4 : birth and 1 month of life |
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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 | Yes |
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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 7 |
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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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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |