Endpoints
The primary endpoint was the proportion of participants requiring additional intravenous FCM to maintain successful correction of ID, based on the diagnostic criteria. Patients were assessed at the five timepoints. Where participants conceived at any time during their follow-up, they were assessed for their final follow up appointment and exited the study.
Secondary endpoints were repeat infusion rate prior to delivery, after delivery and overall during the study period, iron and haematological outcomes (serum iron, ferritin, transferrin and transferrin saturation), maternal pregnancy outcomes and complications (including gestational diabetes), pre-eclampsia, gestational hypertension, preterm labour, pre-labour rupture of membranes, preterm pre-labour rupture of membranes (PPROM), preterm birth, gestational age at birth, antenatal haemorrhage, postpartum haemorrhage, mode of delivery), neonatal outcomes (birth weight, customized birth weight centile, birth length and head circumference) and child neurodevelopment at 12 months of age (Ages and Stages Questionnaire- Third Edition; ASQ).(27) Additional infusions, iron and haematological outcomes were evaluated at the five timepoints.