Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant wome

Phase 3

Active, not recruiting

• Conditions: Anaemia; Low birth weight; Prematurity; Small for Gestational Age; Maternal haemorrhage; Fatigue; Iron Deficiency; Maternal mortality; Infant anaemia; Infant iron deficiency

• Registration Number: ACTRN12618001268235
• Lead Sponsor: niversity of Malawi, College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-27
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 862

Inclusion Criteria

Participants meeting the following criteria will be included in the trial:
1.Confirmed singleton pregnancy at 13-26 weeks gestation
2.Moderate to severe anaemia not requiring an immediate blood transfusion (Hb <10g/dl)
3.Negative malaria parasitaemia
4.Resident in the study catchment area of Blantyre and Zomba district
5.Plan to deliver at a health facility
6.Written informed consent (including assent if <18 years old)

Exclusion Criteria

1.Hypersensitivity to any of the study drugs
2.Clinical symptoms of malaria or bacterial infection
3.Any condition requiring hospitalization or serious concomitant illness
4.Chronic illness that may adversely affect foetal growth and viability
5. Low haemoglobin with symptomatic severe anaemia, requiring a blood transfusion (usually Hb <5g/dl)
6.Previous history of pre-eclampsia

Study & Design

• Study Type: Interventional
• Study Design: Not specified