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

Phase 1

Active, not recruiting

Conditions: Pregnant women
MedDRA version: 20.0Level: HLGTClassification code 10010273Term: Pregnancy, labour, delivery and postpartum conditionsSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2022-001815-25-IE

Lead Sponsor: niversity College Dublin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: Female

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 230
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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