Outcomes
anaemia, death, abortion
ANAEMIA, PREGNANCY LOSS, ADVERSE EVENTS, HYPOPHOSPHATAEMIA, EVENT, POST-PARTUM HAEMORRHAGE, IRON DEFICIENCY, SECONDARY, CLINICAL INFECTION
The primary maternal efficacy outcome was anaemia (venous haemoglobin concentration <11·0 g/dL measured on a Sysmex XP-300 automated analyser [Sysmex, Japan]) at 36 weeks' gestation. The primary maternal outcome was changed during the trial because of guidance introduced by the local ethics committee due to the COVID-19 pandemic.Secondary maternal outcomes included anaemia at 4 weeks' post-infusion and at delivery (venous haemoglobin <11·0 g/dL), and at 4 weeks' post partum (venous haemoglobin <12·0 g/dL). The prevalence of moderate–severe anaemia and change in haemoglobin concentration from baseline were also compared between groups at each timepoint. Iron status (iron deficiency defined as ferritin <15 μg/L or <30 μg/L if C-reactive protein >5 mg/LSafety outcomes included adverse events during ferric carboxymaltose infusion (assessed according to a checklist for women in the active group) and adverse events for any reason from randomisation to 4 weeks' post partum, including serious adverse events (eg, unplanned hospitalisation or death including pregnancy loss and neonatal death), clinical infection episodes, biochemical hypophosphataemia, and positive RDTs. We defined a composite severe maternal event as maternal death, intensive care admission, post-partum haemorrhage, or need for a blood transfusion. We reported abortion, stillbirth, and neonatal death individually and as a combined outcome.The trial provided 24 h midwifery service in the delivery ward, which supported the care of trial participants (and other mothers attending the hospital), enabling measurement of neonatal outcomes.Primary and secondary efficacy outcomes and safety outcomes presented here include those listed in the prespecified statistical analysis plan in support of the primary trial results that were published before the database lock and unblinding. Other outcomes included in the protocol but not included in the statistical analysis plan include outcomes that are explorative or related to substudies.