NCT04228627

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Services Institute of Medical Sciences, Pakistan · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Iron Deficiency (Without Anemia)
• Pregnancy Related

Interventions

Type	Name	Description
DRUG	Parentral Iron	Correction of Iron stores without anaemia

Timeline

• Start date: 2020-01-14
• Primary completion: 2024-01-30
• Completion: 2024-02-28
• First posted: 2020-01-14
• Last updated: 2026-01-15

Locations

3 sites across 1 country: Pakistan