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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621001239853

Acronym

REVAMP-TT

Enrollment

590

Registered

2021-09-14

Start date

2021-11-24

Completion date

2023-02-22

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Antenatal anaemia causes significant risks for both mother and child by amplifying the risks and consequences of serious complications for mothers and their babies. Across Africa, few women receive or take the full recommended course of antenatal oral iron and may present for their initial visit far into the second trimester. We hypothesise that intravenous iron, given as a single rapid infusion of Ferric Carboxymaltose, can assist mothers recovering from anaemia and is superior to the standard of care oral iron tablets.

Interventions

Arm 1: Intravenous Ferric Carboxymaltose (1000 mg for bodyweight > 50 Kg, or 20 mg/Kg for bodyweight < 50 Kg) given once at enrolment as a single infusion over 15 min.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Healthy volunteers

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

Outcome results