This is an open label two-arm Phase III randomized controlled trial in anaemic pregnant women (GA; 27-35 weeks) with the primary maternal outcome of recovery from anaemia and the important secondary neonatal outcome of birth weight. A total of 590 anaemic (Hb >5 but <10g/dl) pregnant women will equally randomised into either (a) IV iron plus Intermittent Preventive Treatment in pregnancy (IPTp) and (b) Oral iron – routine care plus IPTp. The IV iron (1000mg for women with weight >50kg, and 20mg/kg for women with weight <50kg) will be given once at baseline while the oral iron (65mg elemental iron twice daily) will be given for 90 days (or the duration of pregnancy, whichever is shorter).

Both arms receive sulfadoxine pyrimethamine (SP) as IPTp according to national guidelines and participants are being followed up after 4 weeks, then bi-weekly (at home to measure Hb) from 34 weeks’ gestation, as well as clinic visits at 36 weeks’ gestation, at delivery, 1 and 3 months postpartum and thereafter every 3 months until 12 months postpartum. The primary maternal and neonatal outcomes are the prevalence of anaemia (Hb<11g/dl) at 36 weeks’ gestation delivery. The study is being conducted in antenatal clinics in Zomba district, Southern Malawi.

Additionally, an implementation study and health system analysis (REVAMP-IS), conducted in parallel, will assess the feasibility of implementing this intervention in routine antenatal care within the mainstream health system in low-income countries.

Funding

Project Partners

• Training and Research Unit of Excellence
• Walter & Eliza Hall Institute

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