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

Services Institute of Medical Sciences, Pakistan

Status and phase: Completed; Phase 4

Conditions: Iron Deficiency (Without Anemia); Pregnancy Related

Treatments: Drug: Parentral Iron

Study type: Interventional

Funder types: Other

Identifiers

NCT04228627

IRB/2019/599/SIMS

Details and patient eligibility

About

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 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.

Enrollment: 600 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-anaemic iron deficiency

Exclusion criteria

• Anaemia or normal iron stores

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Treatment

Active Comparator group

Description:

Intravenous Iron to correct Iron deficiency without anaemia

Treatment:

Drug: Parentral Iron

Prophylaxis

No Intervention group

Description:

Usual antenatal care