Procedures
ADVERSE EVENTS
Women assigned to the intervention group received a single dose of ferric carboxymaltose (Vifor Pharma, purchased commercially) at 20 mg/kg (up to 1000 mg) diluted in 250 mL normal saline, administered intravenously over 15 mins, at the enrolment visit. Ferric carboxymaltose was infused by study nurses according to a standard operating procedure (Participants were followed up at scheduled visits at 28 days' post-enrolment, 36 weeks' gestation, delivery, and 4 weeks' post partum. Home visits were also scheduled fortnightly at 34, 38, and 40 weeks' gestation to collect capillary haemoglobin and count residual oral iron tablets (control group). During the trial, the study offered a 7-day-a-week service for participants, in which mothers could present for diagnosis and treatment of any symptoms. Women could attend the study centres for unscheduled visits if they became unwell. At each scheduled visit, women were also asked if they (or their neonate) had attended other health providers. This strategy enabled comprehensive capture of adverse events.