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.