REVAMP-TT
Trial question
What is the effect of ferric carboxymaltose for anemia in late pregnancy?
Study design
Multi-center
Open label
RCT
Population
589 female patients.
Inclusion criteria: women at 27-35 weeks of gestation with anemia.
Key exclusion criteria: hypersensitivity to any study drug; clinical symptoms of malaria or other infection; sickle cell or sickle hemoglobin C anemia; clinically unstable with a low hemoglobin level requiring blood transfusion; pre-eclampsia.
Interventions
N=297 ferric carboxymaltose (single intravenous dose of 20 mg/kg up to 1,000 mg).
N=292 standard of care (60 mg elemental iron BID for 90 days).
Primary outcome
Anemia at 36 weeks of gestation or delivery
46.7%
62.7%
62.7 %
47.0 %
31.4 %
15.7 %
0.0 %
Ferric
carboxymaltose
Standard of
care
Significant
decrease ▼
NNT = 6
Significant decrease in anemia at 36 weeks of gestation or delivery (46.7% vs. 62.7%; PR 0.74, 95% CI 0.64 to 0.87).
Secondary outcomes
No significant difference in mean birthweight in infants (2975.1 g vs. 2958.7 g; MD 10.9, 95% CI -65.7 to 87.5).
Significant decrease in iron deficiency anemia at 1 month postpartum (3.7% vs. 22.5%; PR 0.17, 95% CI 0.08 to 0.35).
No significant difference in venous hemoglobin at 1 month of age (12.38 g/dL vs. 12.49 g/dL; MD -0.1, 95% CI -0.44 to 0.24).
Safety outcomes
No significant differences in maternal adverse events, neonatal adverse events.
Conclusion
In women at 27-35 weeks of gestation with anemia, ferric carboxymaltose was superior to standard of care with respect to anemia at 36 weeks of gestation or delivery.
Reference
Sant-Rayn Pasricha, Ernest Moya, Ricardo Ataíde et al. Ferric carboxymaltose for anemia in late pregnancy: a randomized controlled trial. Nat Med. 2025 Jan;31(1):197-206.
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