A single dose of intravenous ferric carboxymaltose failed to improve anemia at 36 weeks gestation compared with oral iron among pregnant women with anemia living in sub-Saharan Africa in a randomized controlled trial. However, ferric carboxymaltose improved iron deficiency and iron deficiency anemia throughout pregnancy and into the postpartum period.
The open-label REVAMP trial, results from which were published in the Lancet, randomly assigned 862 pregnant women between 13- and 26-week gestation to receive ferric carboxymaltose or the standard of care oral elemental iron. All patients also received intermittent malaria prophylaxis. The women were required to have a capillary hemoglobin less than 10.0 g/dL and a negative malaria test. The primary maternal endpoint was anemia at 36 weeks gestation and the primary neonatal outcome was birthweight.
At baseline, the median age was 22 and the median gestational age was 22. The majority of patients had moderate anemia at 76%, followed by 13% with mild, 7% with severe, and 5% with no anemia. Iron deficiency was present among 44% of patients and iron deficiency anemia among 42%.
Inflammation, defined as C-reactive protein levels of greater than 5 mg/L, was present in 51% of patients at baseline. The authors noted that inflammation may have altered maternal and placental iron homeostasis, which could have affected the primary maternal endpoint.
The trial did not meet the primary endpoints. The prevalence of anemia at 36 weeks gestation was similar between the groups, with a rate of 52% and 57% in the ferric carboxymaltose or oral iron groups, respectively (prevalence ratio [PR], 0.92; 95% CI, 0.81-1.06; P =.27).
Birthweights were also similar between the groups, with a mean difference of -3.1 g (95% CI, -75.0 g to 69.9 g; P =.93). There was also no significant difference in birth length.
However, there was a significant reduction in the rates of iron deficiency with ferric carboxymaltose compared with oral iron at delivery (21% vs 39%; PR, 0.53; 95% CI, 0.42-0.66) and 4 weeks postpartum (12% vs 29%; PR, 0.43; 95% CI, 0.30-0.60). Iron deficiency anemia was also decreased at delivery (7% vs 16%; PR, 0.40; 95% CI 0.25-0.62) and 4 weeks postpartum (9% vs 21%; PR, 0.41; 95% CI, 0.27-0.64).
Ferric carboxymaltose was considered safe. The rates of adverse events were 43% and 39% with ferric carboxymaltose and oral iron, respectively. There were no serious adverse events.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of disclosures.
Pasricha S-R, Mwangi MN, Maya E, et al. Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial. Lancet. Published online April 20, 2023. doi: 10.1016/S0140-6736(23)00278-7