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Completed

NCT Number: NCT04228627

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

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.

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Key information

Conditions

Iron Deficiency (Without Anemia) Anemia Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Related

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Allama Iqbal Medical College, Lahore, Punjab Province, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-anaemic iron deficiency

Exclusion criteria

  • Anaemia or normal iron stores

Treatment and study plan

Parentral Iron

Drug

Correction of Iron stores without anaemia

Primary outcomes

  1. Maternal anaemia

    Time frame: 36 weeks' gestation

    Haemoglobin concentration (g/dl)

Secondary outcomes

  1. Fetal growth restriction

    Time frame: At birth

    Birthweight for gestational age (percentile)

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Collaborators

  • Allama Iqbal Medical College
  • Fatima Jinnah Medical University
  • Universidad de Granada

Registry information

Official study title

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

Acronym: FAIR

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 14, 2020
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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