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Ferritin Screening And IRon Treatment for Maternal Anemia and FGR Prevention Trial

Intravenous Iron for Non-anaemic Iron Deficiency in Pregnancy:a Multicenter,Two-arm,Randomised Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04228627
Acronym
FAIR
Enrollment
600
Registered
2020-01-14
Start date
2020-01-14
Completion date
2024-02-28
Last updated
2026-01-15

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

Conditions

Iron Deficiency (Without Anemia), Pregnancy Related

Keywords

anemia, ferritin

Brief summary

Prevalence of anemia in Asia is more than 50%. All woman who book for antenatal care with non-anaemic iron deficiency (NAID) can be offered therapeutic doses of parentral iron, as a directly observed complete therapy, to prevent of maternal anaemia and fetal growth restriction. The investigators will compare this intervention with usual care in a multicentre randomised trial.

Detailed description

Prevalence of anemia (haemoglobin less than 11 gm/dl) in Asia is more than 50% and non-anaemic iron deficiency (ferritin less than 30 microgm/l) or NAID is likely to be more prevalent than this figure. It has been hypothesised that NAID in pregnancy can be linked to maternal fatigue and anaemia, and infant birth weight and growth restriction. The investigators will compare, in NAID, active intervention (therapeutic doses of parentral iron, as a directly observed complete therapy, to replenish iron stores) vs usual care (prophylactic oral iron supplementation) to prevent of maternal anaemia and fetal growth restriction in a multicentre randomised trial.

Interventions

DRUGParentral Iron

Correction of Iron stores without anaemia

Sponsors

Allama Iqbal Medical College
CollaboratorOTHER
Universidad de Granada
CollaboratorOTHER
Fatima Jinnah Medical University
CollaboratorOTHER
Services Institute of Medical Sciences, Pakistan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

Allocation concealment

Intervention model description

Multi centre randomised trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Non-anaemic iron deficiency

Exclusion criteria

* Anaemia or normal iron stores

Design outcomes

Primary

MeasureTime frameDescription
Maternal anaemia36 weeks' gestationHaemoglobin concentration (g/dl)

Secondary

MeasureTime frameDescription
Fetal growth restrictionAt birthBirthweight for gestational age (percentile)

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026