ACTRN12621001239853
Completed
Phase 3
Effectiveness of intravenous iron administered during the third trimester in Malawian women in the management of anaemia: a 4-year, multicentre, parallel-group, two-arm, open-label randomised controlled superiority trial
Training and Research Unit of Excellence (TRUE), Malawi0 sites590 target enrollmentSeptember 14, 2021
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Anaemia
- Sponsor
- Training and Research Unit of Excellence (TRUE), Malawi
- Enrollment
- 590
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed singleton pregnancy in the third trimester (27\-35 weeks of gestation, dated by Last Menstrual Period)
- •Moderate to severe anaemia not requiring an immediate blood transfusion (Hb \<10 g/dl)
- •Negative malaria parasitaemia by mRDT
- •Currently afebrile with no evidence of septicaemia
- •Resident in the study catchment area of Zomba district (Malawi)
- •Able to deliver at health facilities within Zomba district (Malawi)
- •Written informed consent (including assent if \<18 years old)
Exclusion Criteria
- •Previous enrolment in REVAMP trial – ACTRN12618001268235\.
- •Actively participating in another intervention trial.
- •Known hypersensitivity to any of the study drugs.
- •Clinical symptoms of malaria or other infection (no fever, no focal symptoms of internal infection i.e. LRTI/ diarrhoea).
- •Any condition requiring hospitalisation in the next seven days or serious concomitant illness.
- •Known history of sickle cell or sickle\-haemoglobin C anaemia.
- •Clinically low haemoglobin level requiring a blood transfusion (usually Hb \<5g/dl).
- •Preeclampsia
Outcomes
Primary Outcomes
Not specified
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