Safety and Effectiveness of Intravenous Ferric Carboxymaltose for Moderate Anaemia in Pregnancy
DOI:
https://doi.org/10.52609/jmlph.v6i1.272Keywords:
Ferric Carboxymaltose, Hemoglobin, Intravenous Iron, Iron Deficiency, Pregnancy Anemia, Serum FerritinAbstract
Background: Anaemia in pregnancy is a major global health concern linked to adverse maternal and foetal outcomes. Intravenous ferric carboxymaltose (FCM) is a relatively new therapy that enables rapid correction of iron deficiency with minimal adverse effects.
Aim: To evaluate the safety and effectiveness of intravenous FCM in pregnant women with moderate anaemia during the second and third trimesters.
Methods: This prospective observational study was conducted at the Department of Obstetrics and Gynaecology of the Government Medical College in Srinagar, India, over 18 months. One hundred pregnant women with moderate anaemia (Hb 7–9.9 g/dL) received a single intravenous infusion of FCM (maximum 1000 mg). Haemoglobin and serum ferritin levels were measured before and four weeks after infusion. Adverse events and fetal outcomes were monitored.
Results: Mean baseline haemoglobin was 7.81 ± 0.43 g/dL, which increased to 9.47 ± 0.48 g/dL (p < 0.001). Mean serum ferritin rose from 16.70 ± 6.97 ng/mL to 122.20 ± 15.98 ng/mL (p < 0.001). Only 2% of participants experienced minor allergic reactions; no serious maternal or fetal adverse events occurred.
Conclusion: FCM is a safe and effective option for treating moderate anaemia in pregnancy, offering rapid correction with minimal side effects.
References
World Health Organization. Guideline on haemoglobin cutoffs to define anaemia in individuals and populations. Geneva: World Health Organization; 2024. Availa-ble from: https://www.who.int/publications/i/item/9789240088542.
Good clinical practice recommendations for iron deficiency anemia in pregnancy (IDA) in pregnancy in India. J Obstet Gy-naecol India. 2011;61(5):569–571. doi: 10.1007/s13224-011-0097-5.
World Health Organization. The global prevalence of anaemia in 2011 [Internet]. Geneva: World Health Organization; 2015 [cited 2023 Apr 2]. Available from: https://apps.who.int/iris/handle/10665/177094.
Verbunt E, Hasan MI,Davidson EM, Ah-med S, McLean ARD, Quaiyum Rahman AM, et al. Testing and treating anaemia in pregnant women in Bangladesh: a cross-sectional survey. BMJ Public Health. 2025;3(2):e002167. doi:10.1136/bmjph-2024-002167.
International Institute for Population Sci-ences (IIPS) and ICF. National Family Health Survey (NFHS-5), India, 2019–21: Fact Sheets. Mumbai: IIPS; 2020 [Inter-net]. Available from: https://rchiips.org/nfhs/NFHS-5_FCTS/India.pdf
Nisar YB, Dibley MJ, Aguayo VM. Iron–folic acid supplementation during pregnan-cy reduces the risk of stunting in children less than 2 years of age: a retrospective co-hort study from Nepal. Nutrients. 2016;8(2):67. doi: 10.3390/nu8020067.
World Health Organization. Anaemia in women and children: WHO global anaemia estimates, 2025 edition (trends 2000–2023). Geneva: World Health Organiza-tion; 2025. Available from: https://www.who.int/data/gho/data/themes/topics/anaemia_in_women_and_children.
Shisana O, Labadarios D, Rehle T, Simba-yi L, Zuma K, Dhansay A, et al. South Af-rican National Health and Nutrition Exam-ination Survey (SANHANES-1). Cape Town: HSRC Press; 2013.
Al-Jawaldeh A, Taktouk M, Doggui R, Abdollahi ZF, Achakzai BK, Aguenaou H, et al.Are countries of the Eastern Mediter-ranean Region on track towards meeting the World Health Assembly target for anemia? A review of evidence. Int J Envi-ron Res Public Health. 2021 Mar 2;18(5):2449.
Daru J, Zamora J, Fernández-Félix BM, Vogel J, Oladapo OT, Morisaki N, et al. Risk of maternal mortality in women with severe anaemia during pregnancy and postpartum: a multilevel analysis. Lancet Glob Health. 2018;6(5):e548–e554. doi: 10.1016/S2214-109X(18)30078-0.
Kavle JA, Landry M. Addressing barriers to maternal nutrition in low- and middle-income countries: a review of the evidence and programme implications. Matern Child Nutr. 2018;14(1):e12508. doi: 10.1111/mcn.12508.
Kapil U, Bhadoria AS. National Iron-plus Initiative guidelines for control of iron de-ficiency anaemia in India, 2013. Natl Med J India. 2014;27(1):27–29.
Kapil U, Kapil R, Gupta A. National Iron Plus Initiative: Current status and future strategy. Indian J Med Res. 2019;150(3):239–247. doi: 10.4103/ijmr.IJMR_1782_18. PMID: 31719294; PMCID: PMC6886130.
Ministry of Health and Family Welfare, Government of India. Anemia Mukt Bha-rat: Intensified National Iron Plus Initiative (NIPI) for accelerating annual rate of de-cline of anemia. New Delhi: MoHFW; 2018 [Internet]. Available from: https://nhm.gov.in/images/pdf/programmes/child-health/nutrition/Anemia_Mukt_Bharat.pdf.
Ministry of Health and Family Welfare, Government of India. Adolescent anemia control: guidelines for programme manag-ers. New Delhi: MoHFW; 2019 [Internet]. Available from: https://nhm.gov.in/images/pdf/programmes/child-health/nutrition/Adolescent_Anemia_Control.pdf
World Health Organization. Haemoglobin concentrations for the diagnosis of anae-mia and assessment of severity [Internet]. Geneva: World Health Organization; 2011 [cited 2023 Apr 2]. Available-from:https://www.who.int/vmnis/indicators/haemoglobin.pdf.
Breymann C, Milman N, Mezzacasa A, Bernard R, Dudenhausen J; FER-ASAP investigators. Ferric carboxymaltose vs. oral iron in the treatment of pregnant women with iron deficiency anemia: an in-ternational, open-label, randomized con-trolled trial (FER-ASAP). J Perinat Med. 2017;45(4):443–453. doi: 10.1515/jpm-2016-0050. PMID: 27278921.
Seid MH, Derman RJ, Baker JB, Banach W, Goldberg C, Rogers R. Ferric carbox-ymaltose injection in the treatment of postpartum iron deficiency anemia: a ran-domized controlled clinical trial. Am J Ob-stet Gynecol. 2008;199(4):435.e1–7. doi: 10.1016/j.ajog.2008.07.046. PMID: 18928998.
Christoph P, Schuller C, Studer H, Irion O, De Tejada BM, Surbek D. Intravenous iron treatment in pregnancy: comparison of high-dose ferric carboxymaltose vs. iron sucrose. J Perinat Med. 2012;40(5):469–474. doi: 10.1515/jpm-2011-0231. PMID: 22945271.
Mahey R, Kriplani A, Mogili KD, Bhatla N, Kachhawa G, Saxena R. Randomized controlled trial comparing ferric carboxy-maltose and iron sucrose for treatment of iron deficiency anemia due to abnormal uterine bleeding. Int J Gynaecol Obstet. 2016;133(1):43–48. doi: 10.1016/j.ijgo.2015.09.007. PMID: 26868063.
Beckert RH, Baer RJ, Anderson JG, Jel-liffe-Pawlowski LL, Rogers EE. Maternal anemia and pregnancy outcomes: a popula-tion-based study. J Perinatol. 2019;39(7):911–919. doi: 10.1038/s41372-019-0375-0. PMID: 30967656.
Drukker L, Hants Y, Farkash R, Ruchle-mer R, Samueloff A, Grisaru-Granovsky S. Iron deficiency anemia at admission for la-bor and delivery is associated with an in-creased risk for cesarean section and ad-verse maternal and neonatal outcomes. Transfusion. 2015;55(12):2799–2806. doi: 10.1111/trf.13252. PMID: 26246160.
Froessler B, Collingwood J, Hodyl NA, Dekker G. Intravenous ferric carboxymalt-ose for anaemia in pregnancy. BMC Preg-nancy Childbirth. 2014;14:115. doi: 10.1186/1471-2393-14-115. PMID: 24667031; PMCID: PMC3986933.
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