Daily versus alternate day oral iron supplementation for the treatment of iron deficiency anaemia in pregnancy (IronMother)
- Conditions
- Iron deficiency anaemia in pregnancy
- Registration Number
- 2024-512064-61-00
- Lead Sponsor
- University College Dublin
- Brief Summary
To determine whether alternate day oral iron is noninferior to daily oral iron for the treatment of iron deficiency
anaemia by comparing haemoglobin level (Hb) between the
two arms after 4 weeks of therapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ended
- Sex
- Female
- Target Recruitment
- 230
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 visit 1
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
Women <18 years of age
Allergy/sensitivity to Galfer or their ingredients
Subjects unable to provide written informed consent or who require an interpreter
Known 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 Hb levels at 4 weeks post IMP treatment Hb levels at 4 weeks post IMP treatment
- Secondary Outcome Measures
Name Time Method Compliance as measured by objective pill count at 4 week assessment Compliance as measured by objective pill count at 4 week assessment
Serum ferritin levels in both groups after 4 weeks treatment Serum ferritin levels in both groups after 4 weeks treatment
Compliance as measured by questionnaire at 4 week assessment Compliance as measured by questionnaire at 4 week assessment
Tolerance as measured by gastrointestinal symptom questionnaire at 4 week assessment Tolerance as measured by gastrointestinal symptom 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) 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)
Trial Locations
- Locations (1)
The National Maternity Hospital
🇮🇪Dublin 2, Ireland
The National Maternity Hospital🇮🇪Dublin 2, IrelandJennifer WalshSite contact0035316373216jwalsh@nmh.ie