The use of iron administered as an infusion into a vein compared to the use of iron tablets taken by mouth for treating Nigerian women with iron deficiency anaemia during pregnancy

Phase 3

• Conditions: Haematological Disorders; Nutritional, Metabolic, Endocrine; Pregnancy and Childbirth; Maternal anaemia, preterm birth, maternal depression and low birth weight

• Registration Number: PACTR202012843695208
• Lead Sponsor: niversity of Lagos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Other
• Sex: Female
• Target Recruitment: 1056

Inclusion Criteria

1. Pregnant women aged 15 to 49 years old.
2. Gestational age 20- and 32-weeks.
3. Baseline (enrollment) laboratory-confirmed moderate or severe anemia (Hb < 10g/dl).

Exclusion Criteria

1. Medically-confirmed significant bleeding, major surgery or received blood transfusion within the last 3 months
2. Symptomatic anemia with dyspnea or fatigue and a need for urgent correction
3. Concurrent anemia of another cause besides IDA.
4. Clinically-confirmed malabsorption syndrome or hypersensitivity to any form of iron treatment.
5. Preexisting maternal depression or other psychiatric illness
6. History of any immune related illness e.g., SLE, Rheumatoid arthritis.
7. Severe allergic reactions such as severe asthma.
8. Women with known drug allergies

Study & Design

• Study Type: Interventional
• Study Design: Not specified