E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | HLGT |
E.1.2 | Classification code | 10010273 |
E.1.2 | Term | Pregnancy, labour, delivery and postpartum conditions |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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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 determine whether alternate day oral iron is non-inferior to daily oral iron for the treatment of iron deficiency anaemia by comparing haemoglobin (Hb) between the two arms after 4 weeks of therapy |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives will be to compare compliance, tolerance and the incidence of GI side-effects in both groups, compare serum haemoglobins in both groups at term (37-42 weeks’ gestation) and compare obstetric and neonatal outcomes. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
● Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol ● Subjects must be aged 18 years or above at baseline ● Subjects will need to have a standard of English good enough to understand and read the information leaflet and consent form and communicate easily with the research team. ● A diagnosis of IDA as defined by Hb <10.5g/dL but not ≤7g/dl and a serum ferritin of <30µg/L ● Singleton pregnancies ● Gestational age of 14- 34 weeks’ gestation ● A level of English high enough for informed consent and study participation
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E.4 | Principal exclusion criteria |
● Women <18 years of age ● Allergy/sensitivity to Galfer or their ingredients ● Subjects unable to provide written informed consent or who require an interpreter ● Presence of an underlying haemoglobinopathy ● Severe anaemia as defined by Hb ≤7g/dl ● Subjects who have any other significant disease or disorder (including inflammatory bowel disease, haemochromatosis, haemoglobinopathy, any active inflammatory diseases, malabsorptive conditions) which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study. ● Any underlying medical disorder or medications that the research team feel would impact iron absorption eg. Hyperemesis, Coeliac’s disease, inflammatory bowel disease, anaemia of chronic disease or anaemia related to other causes (B12/Folate), previous bariatric surgery, active PUD, haemochromatosis ● Multiple pregnancy ● Not taking medications in a way which could potentially hinder the absorption of iron eg. PPIs, Antacids, levothyroxine all need to be taken separately to iron
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E.5 End points |
E.5.1 | Primary end point(s) |
● Hb levels at 4 weeks post randomisation |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
4 weeks post randomisation |
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E.5.2 | Secondary end point(s) |
● Compliance as measured by objective pill count at 4 week assessment ● Serum ferritin levels in both groups after 4 weeks treatment ● Compliance as measured by validated questionnaire at 4 week assessment ● Tolerance as measured by validated gastrointestinal symptoms questionnaire at 4 week assessment ● Obstetric and neonatal outcomes : o Delivery outcomes (livebirth, stillbirth, NND) o Mode of delivery (OVD, SVD, LSCS) o Rates and quantitation of primary PPH o Postnatal blood transfusion in the two weeks post-delivery (Y/N, if yes for RCC no. of units) o Postnatal iron transfusion in the two weeks post-delivery o Neonatal Intensive Care Unit admission (Y/N) o Apgar scores (at 1 and 5 minutes of life as standard) o Birth weights o Most recent Hb levels at term (37-42 wks gestation)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoints provided in E.5.2. |
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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 | 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 | 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 |
Same drug. Arm 1 will take the drug every day, arm 2 will take the drug every second day |
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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
| 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 | 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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The end of trial will be 2 weeks after the last infant delivery of the recruited patients. |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |