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An infusion of ferric carboxymaltose in the third trimester significantly reduced anemia in pregnant women, surpassing the efficacy of iron tablets.
A single infusion of intravenous (IV) ferric carboxymaltose (FCM) in the third trimester of pregnancy can significantly lower the occurrence of anemia before childbirth, outperforming the efficacy of iron tablets, according to a new study.1
In one of the largest trials evaluating iron deficiency, conducted among nearly 600 pregnant women in antenatal clinics in Malawi, these data revealed a lower anemia prevalence in those receiving infusions (46.7%), compared with iron tablets (62.7%), at the time of delivery.
“While anemia is one of the most avoidable causes of illness and death in resource-poor nations, any woman across the world can become anemia during pregnancy, highlighting how this remains a global priority,” Sant-Rayn Pasricha, MBBS, MPH, PhD, head of the anemia research laboratory at the Walter and Eliza Hall Institute of Medical Research, said in a statement.2 “We found that a single iron infusion in the third trimester can achieve what oral iron tablets taken every day during pregnancy cannot.”
REVAMP-TT was an open-label, parallel-group, individually randomized controlled trial conducted in primary healthcare settings in southern Malawi, a low-income country in southern sub-Saharan Africa. Sub-Saharan Africa reports an anemia prevalence rate of approximately 46%, compared with the 36.5% rate globally.3
Recommendations from the World Health Organization (WHO) suggest treating antenatal anemia with oral iron supplementation, but time before the onset of labor can be limited for oral iron intervention to restore hemoglobin levels. Adherence to sufficient oral iron can also be an issue, as only 29% of pregnant women in sub-Saharan Africa consume an adequate treatment course.4
FCM is an IV iron formulation allowing up to 1000 mg administered in a single 15-minute infusion, widely used in high-income settings to avoid transfusions during late pregnancy.5 In REVAMP-TT, Pasricha sought to determine the superiority of a single dose of intravenous FCM to oral iron in reducing anemia prevalence at either 36 weeks’ gestation or delivery and how it would improve key maternal and neonatal outcomes.1
Between November 2021 and February 2023, 8195 women were screened for eligibility, of which 590 were enrolled and randomized. The final 4-week postpartum visit occurred in June 2023. For the FCM arm, 263 of 297 patients (88.6%) received 1000 mg and the rest (11.4%) weighed <50 kg and received a lower dose.
Upon analysis, anemia at 36 weeks gestation or delivery occurred in 126 of 270 (467%) women in the FCM group, compared with 170 of 271 (67.3%) women in the standard-of-care oral iron group (prevalence ratio [PR], 0.74; 95% CI, 0.64–0.87; P = .0002). Average birthweight did not differ in infants born to mothers receiving FCM or oral iron (mean difference, 10.9 g (95% CI, –65.7 to 87.5; P = .78).
Secondary outcome analysis found FCM reduced anemia prevalence, compared with oral iron, at both the time of delivery (20.7% vs. 34.9%; PR, 0.61 [95% CI, 0.46–0.81) and 1 month postpartum (36.0% vs. 57.9%; PR, 0.62 [95% CI, 0.51–0.75]). Safety outcomes revealed no serious infusion-related adverse events, without medical intervention required for any infusion reaction, between the study cohorts.
Pasricha and colleagues noted that, if these data prove IV iron could be safely provided in basic health centers in a remote country, all health settings should be able to safely and effectively increase the uptake of IV iron.2 They also indicated plans to share these data with the WHO to boon future global antenatal care guidelines.
“This sustained impact on anemia is an unprecedented finding that really crystalizes the case for using infusions in late pregnancy to rapidly boost red blood cell production and iron levels,” Pasricha added.2 “We hope our findings will soon be translated in health settings across the world to form a uniform set of guidelines that can ensure more women get the right iron treatment when they need it most.”
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