E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
post partum anemia is generally treated by ferrous fumarate. It is unclear whether the addition of folic acid to ferrous fumarate in the treatment of anaemia could accelerate the increase of haemoglobin. Secondly, health status of post-partum women will be studied in relation tho anaemic and non-anaemic status |
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MedDRA Classification |
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 |
What is the difference in haemoglobin increase in women with post partum anaemia (Hb ≥4,0mmol/l and < 6,5 mmol/l) treated with iron supplementation versus iron plus folic acid supplementation, in a treatment period of 4 weeks? |
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E.2.2 | Secondary objectives of the trial |
1. What is the difference in HS (measured in CIS, RAND-36 and EQ-5D questionnaires). between anaemic (Hb<6,5mmol/l) and non-anaemic (Hb≥6,5mmol/l) women, directly post partum and 4 weeks after delivery. And what is the change in HS in women with post partum anaemia treated with iron supplementation versus iron plus folic acid supplementation, in a treatment period of 4 weeks? 2. To establish retrospectively whether the CHr may be used as a better parameter then haemoglobin to determine the need of iron treatment with or without folic acid in women directly post-partum. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Women aged > 18 years 2. 0-48 hours after delivery 3. Patients are in a clinical obstetric setting 4. Thorough grasp of the Dutch language 5. Informed consent acceptance
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E.4 | Principal exclusion criteria |
1. Pernicious anaemia (Vitamin B12 deficiency) 2. Packed cells infusion in the previous 3 months 3. Alcohol addiction 4. Drug addiction 5. Chronic infection 6. Gastro-intestinal disease or condition (excl. IBS, constipation and diarrhoea) 7. Thalassemia 8. Haemoglobinopathy (Sickle-cell anaemia) 9. Aplastic anaemia 10. Megaloblastic anaemia 11. Haemolytic anaemia and HELLP 12. Malignant disease 13. Kidney failure 14. Liver failure 15. Bone marrow disease
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study parameter is the amount of increase of haemoglobin (mmol/l) four weeks after delivery in both anaemic sub-groups. Secondary study parameters will be the difference in health status between the anaemic and non-anaemic groups, and between both anaemic sub-groups four weeks after delivery, measured using the RAND-36, CIS and EQ-5D questionnaires. And the observed difference in CHr between the anaemic and non-anaemic groups, and between both anaemic sub-groups four weeks after delivery. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |