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Early Intervention With IV Iron Is Safe, Effective for Anemia During Pregnancy
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Compared with daily oral iron, a single intravenous (IV) infusion of iron was shown to lower rates of low birth weight in infants and decrease reliance on further iron supplementation or transfusions in pregnant patients with anemia.
According to an abstract of a parallel, 3-arm, semi-blind superiority randomized controlled multicenter trial, single dose intravenous (IV) iron resulted in a reduced incidence of low birth weight (LBW) infants and a higher incidence of attaining maternal non-anemic status (NAS) compared with oral iron as a first-line treatment for moderate maternal anemia due to iron deficiency.1,2
Anemia during pregnancy can cause adverse outcomes for both the mother and child. | Image Credit: © loran4a - stock.adobe.com
The data, presented at the Society for Maternal-Fetal Medicine’s (SMFM) 2025 Pregnancy Meeting, could serve as a basis for new clinical guidelines that address the benefits of single-dose IV iron as a primary treatment for iron deficient anemia that occurs during pregnancy. Anemia remains a health challenge globally, with anemia during pregnancy affecting an estimated 37% of pregnant patients.1,2
Maternal anemia with iron deficiency corresponds with an increased risk of adverse perinatal outcomes, according to study investigators. These can include going into labor early, hemorrhaging, and death. Anemia during pregnancy can also have detrimental long-term implications for infants. Current obstetric guidelines recommend first-line treatment with twice daily oral iron, with IV iron advocated only in the case of severe anemia and typically in the third trimester. But as the authors note, rates of iron deficiency anemia in pregnancy are above global targets and continue to rise.1,2
“Studies have shown that maternal iron deficiency anemia early in pregnancy is most strongly correlated with adverse outcomes, including short-term infant outcomes such as LBW and longer-term childhood outcomes, including autism and schizophrenia,” Rupsa C Boelig, MD, MS, a maternal-fetal medicine subspecialist and co-author of the study, said in a news release. “There is a need to intervene earlier and aggressively address anemia.”1
Because of this unmet need, the investigators conducted this trial to determine whether single-dose IV iron in the second trimester is superior to twice-daily oral iron in reducing LBW infants and maternal anemia at delivery. The trial is one of the largest studies to date utilizing IV iron in pregnancy; India was selected as the site of the trial due to the high prevalence of anemia in the country. Patients were randomized 1:1:1 to receive either standard care of 60 mg oral ferrous sulfate twice daily; a single dose infusion of IV ferric derisomaltose (FDM); or a single dose infusion of IV ferric carboxymaltose (FCM). The latter IV groups were selected due to their status as the only IV iron formulations approved for use in India.1,2
“What’s unique about this study is that we did the iron intervention early in the second trimester. Many other studies comparing IV iron to oral iron are initiated in the third trimester,” Boelig continued. “Iron requirements increase dramatically during pregnancy, [and specifically] increase dramatically during the second trimester, so it’s much more difficult to catch up if you’re intervening in the third trimester."1
A total of 1450, 456, and 1462 participants were included in the oral iron, FDM, and FCM groups, respectively. Investigators observed a reduced rate of LBW with IV FCM (25.2%, RR = 0.87; 97.55% CI, 0.75-0.99), P = .017), but not IV FDM (29.1%, RR = 0.98; 97.55% CI, 0.86-1.12; P = .71), compared with oral iron (29.3%). Furthermore, achievement of NAS was not improved in IV FCM (RR = 1.05; 99.95% CI, 0.97-1.15) and IV FDM (RR = 1.06; 99.95% CI, 0.98-1.16) vs oral iron (69.7%). However, in a sensitivity analysis, investigators noted an increased rate of NAS in both IV FDM (RR = 1.25 [1.13-1.396]; P < .0001) and IV FCM (RR = 1.24 [1.12-1.38], P < .0001) compared with oral iron.2
Overall, the investigators found that, as a first-line treatment of moderate maternal iron deficiency anemia, a single-dose infusion of IV iron results in a reduced incidence of LBW in infants (observed with IV FCM vs oral iron) and a heightened incidence of attaining maternal NAS without necessitating further iron or blood transfusion (observed with both IV FCM and IV FDM vs oral iron). These results indicate that “single dose IV iron preparations are safe and easy to administer under proper supervision and facilities... to treat anemia in pregnancy,” according to Mrutyunjaya B Bellad, MD, professor in the Department of Obstetrics and Gynecology at JN Medical College in Belagavi, India.1
