Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women in their third trimester: REVAMP-TT

Phase 3

Completed

• Conditions: Anaemia; Iron-deficiency; Hypophosphataemia; Foetal anaemia; Infection; Child development; Maternal depression; Blood - Anaemia; Mental Health - Depression; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12621001239853
• Lead Sponsor: Training and Research Unit of Excellence (TRUE), Malawi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-14
• Study Completion: 2024-05-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 590

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of women with anaemia (defined as venous blood Hb < 11.0 g/dL) at 36 weeks’ gestation or at delivery, whichever comes first. This will be determined by a Sysmex haematology analyser.[ 36 weeks’ gestation or at delivery, whichever comes first.]