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

Phase 4

Active, not recruiting

• Conditions: Iron Deficiency (Without Anemia); Pregnancy Related
• Interventions: Drug: Parentral Iron

• Registration Number: NCT04228627
• Lead Sponsor: Services Institute of Medical Sciences, Pakistan

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.

Study Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-11
• Study First Posted: 2020-01-14
• Study Start: 2020-08-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-21
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Non-anaemic iron deficiency

Exclusion Criteria

• Anaemia or normal iron stores

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Parentral Iron	Intravenous Iron to correct Iron deficiency without anaemia

Primary Outcome Measures

Name	Time	Method
Maternal anaemia	36 weeks' gestation	Haemoglobin concentration (g/dl)

Secondary Outcome Measures

Name	Time	Method
Fetal growth restriction	At birth	Birthweight for gestational age (percentile)

Trial Locations

Locations (3)

Fatima Jinnah Medical University; 🇵🇰 Lahore, Punjab, Pakistan

TAYYIBA Wasim; 🇵🇰 Lahore, Punjab, Pakistan

Allama Iqbal Medical College; 🇵🇰 Lahore, Punjab, Pakistan