Daily versus alternate day oral iron supplementation for the treatment of iron deficiency anaemia in pregnancy (IronMother)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 230

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether alternate day oral iron is noninferior to daily oral iron for the treatment of iron deficiency <br>anaemia by comparing haemoglobin level (Hb) between the <br>two arms after 4 weeks of therapy;Secondary Objective: Secondary objectives will be to compare compliance, tolerance and the incidence of GI side-effects in both groups, compare haemoglobin levels in both groups at term (37-42 weeks’ gestation) and compare obstetric and neonatal outcomes;Primary end point(s): Hb levels at 4 weeks post randomisation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Compliance as measured by objective pill count at 4 week assessment;Secondary end point(s):Serum ferritin levels in both groups after 4 weeks treatment;Secondary end point(s):Compliance as measured by questionnaire at 4 week assessment;Secondary end point(s):Tolerance as measured by gastrointestinal symptom questionnaire at 4 week assessment;Secondary end point(s):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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