Interventions
The intervention was intravenous ferric carboxymaltose (FCM), 500 mg or
1000mg, in 250ml of normal saline, infused over 30 minutes. At the first
appointment after screening, FCM at the randomised dose was
administered.
Iron status was monitored at five study timepoints: 4 weeks after the
initial infusion, then at 6 weeks-, 3-, 6- and 12- months postpartum, or
at the time of next pregnancy, whichever came first. The diagnostic
criteria indicating persistent ID and requiring additional IVI were
ferritin <30 μg/l plus transferrin saturation <25%,
or, if inflammation were present (CRP >7.9 ng/l), ferritin
between 30 and 50 μg/l plus a transferrin saturation <20%. If
confirmed, ID was treated with a single 500mg FCM infusion in both
groups.