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

Completed

• Conditions: Iron deficiency anaemia in pregnant women; Pregnancy and Childbirth; Iron deficiency anaemia in pregnancy

• Registration Number: ISRCTN63484804
• Lead Sponsor: niversity of Lagos

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36076211/ (added 09/09/2022) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38347614/ Qualitative study (added 13/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-10
• Study Completion: 2023-06-15
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

Current exclusion criteria as of 27/06/2022:

1. Medically confirmed significant bleeding, major surgery or received blood transfusion within the last 3 months.
2. Severe symptomatic anemia needing urgent correction with blood transfusion.
3. Anemia of other cause besides IDA e.g., Sickle cell anemia.
4. Clinically confirmed malabsorption syndrome.
5. Hypersensitivity to any form of iron treatment.
6. History of any immune related illness e.g., SLE, Rheumatoid arthritis.
7. Preexisting maternal depression or other psychiatric illness.
8. Severe allergic reactions such as severe asthma.
9. History of severe drug allergy.

_____

Previous exclusion criteria:

1. Medically confirmed significant bleeding, major surgery or received a blood transfusion within the last 3 months
2. Symptomatic anaemia with dyspnea or fatigue and a need for urgent correction
3. Concurrent anaemia 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified