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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512064-61-00
Enrollment
230
Registered
2024-05-17
Start date
2023-04-21
Completion date
2025-05-01
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency anaemia in pregnancy

Brief summary

Hb levels at 4 weeks post IMP treatment

Detailed description

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 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)

Interventions

DRUGGalfer 305mg Hard Capsules

Sponsors

University College Dublin
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Hb levels at 4 weeks post IMP treatment

Secondary

MeasureTime frame
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 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)

Countries

Ireland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026