Treatments
ADVERSE REACTIONS
Treatment was initiated at the baseline visit. After baseline data were collected, women allocated to the IV iron group received a single dose of 1000 mg FDI diluted in 100 mL 0.9% sodium chloride (or if pre-pregnancy body weight was < 50 kg, the dose was 20 mg/kg based on pre-pregnancy body weight). Infusions were administered over approximately 20 min and participants were observed for adverse reactions during, and 30 min after, the end of the infusion. Women in the oral iron group received ferrous fumarate tablets (equivalent to 100 mg elemental iron) combined with 60 mg ascorbic acid for self-administration once daily throughout the trial (i.e., 18 weeks). Compliance was encouraged at each visit and assessed by pill count at Weeks 6 and 18. Regardless of initial allocation, all participants presenting with IDA (Hb < 11.0 g/dL and ferritin < 30 µg/L) at the 6 or 12-week visits were offered an additional IV iron infusion, dosed and administered in the same way as described for the baseline visit. In women who received additional IV iron at, or after, 26 weeks gestational age, foetal heart rate was monitored with cardiotocography. Participants in the oral iron group who received additional IV iron stopped oral iron therapy when IV treatment was initiated.