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

Overview

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.

Full Title of Study: “Ferritin Screening And IRon Treatment for Maternal Anemia and Fetal Growth Restriction (FGR) Prevention – a Multi Centre Randomised Controlled Trial (RCT)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 30, 2021

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

  • Drug: Parentral Iron
    • Correction of Iron stores without anaemia

Arms, Groups and Cohorts

  • Active Comparator: Treatment
    • Intravenous Iron to correct Iron deficiency without anaemia
  • No Intervention: Prophylaxis
    • Usual antenatal care

Clinical Trial Outcome Measures

Primary Measures

  • Maternal anaemia
    • Time Frame: 36 weeks’ gestation
    • Haemoglobin concentration (g/dl)

Secondary Measures

  • Fetal growth restriction
    • Time Frame: At birth
    • Birthweight for gestational age (percentile)

Participating in This Clinical Trial

Inclusion Criteria

  • Non-anaemic iron deficiency

Exclusion Criteria

  • Anaemia or normal iron stores

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Services Institute of Medical Sciences, Pakistan
  • Collaborator
    • Allama Iqbal Medical College
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tayyiba Wasim, Professor – Services Institute of Medical Sciences, Pakistan
  • Overall Official(s)
    • TAYYIBA Wasim, Principal Investigator, Services Institute of Medical Sciences, Pakistan
  • Overall Contact(s)
    • TAYYIBA Wasim, 03008400197, tayyibawasim@yahoo.com

References

Pratt JJ, Khan KS. Non-anaemic iron deficiency – a disease looking for recognition of diagnosis: a systematic review. Eur J Haematol. 2016 Jun;96(6):618-28. doi: 10.1111/ejh.12645. Epub 2015 Sep 17. Review.

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