Treatment of Nigerian women with Iron by drip or iron tablets taken by mouth, for low blood level, hours after delivery

Phase 3

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

• Registration Number: ISRCTN51426226
• Lead Sponsor: niversity of Lagos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-03
• Last Update Posted: 26 August 2024
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 1400

Inclusion Criteria

1. Women aged between 15 and 49 years
2. Between 6 and 48 hours after delivery
3. Baseline (enrollment) moderate or severe anemia (Hb = 9.9g/dl), confirmed by Hemocue haemoglobinometer
4. Able and willing to give written informed consent

Exclusion Criteria

1. Having received a blood transfusion, for any indication, within the last 3 months
2. Symptomatic anemia and a need for urgent correction
3. Known haemoglobinopathy such as sickle cell disease, HbCC disease
4. Clinically confirmed malabsorption syndrome
5. Known hypersensitivity or contraindication to any form of iron treatment, study drug or any of its excipients
6. Self-reported pre-existing maternal depression or other psychiatric illness and as evidenced by a YES response to any past history of psychiatry ward hospitalization, psychiatry medications, behavioral changes, or past consultation with psychiatry services
7. Severe allergic conditions such as severe asthma, eczema or other atopic condition
8. Known autoimmune conditions e.g., systemic lupus erythematosus, rheumatoid arthritis or known severe drug allergies.
9. Planning to move or reside outside the research area

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 31/07/2024: <br><br>Proportion of participants who are anemic at six weeks postpartum. An anemic state is defined as hemoglobin level of < 11.0 g/dL, measured using haemoglobin levels at 6weeks postpartum<br><br>____<br><br>Previous primary outcome measure:<br><br>Proportion of participants who are non-anaemic at six weeks postpartum. Non-anaemic state is defined as haemoglobin level = 11.0g/dl, measured using haemoglobin levels at 6weeks postpartum