Pregnant women MedDRA version: 20.0 Level: HLGT Classification code 10010273 Term: Pregnancy, labour, delivery and postpartum conditions System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Interventions
Trade Name: Galfer
Product Name: Galfer
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Galfer
CAS Number: 141-01-5
Other descriptive name: FERROUS FUMARATE
Concentration unit: mg milligram(s)
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: 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.;Primary end point(s): ?Hb levels at 4 weeks post randomisation;Timepoint(s) of evaluation of this end point: 4 weeks post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) ;Timepoint(s) of evaluation of this end point: Timepoints provided in E.5.2. | — |
Countries
Ireland
Contacts
Public ContactUCD monitoring
UCD
Outcome results
None listed