Retrospective observational study to assess clinical impact of ferric pyrophosphate supplementation in antenatal settings of India (FEMINA study)

Alpesh Gandhi; Hemant Bhatt; Meeta Patel; Prajakta Nidhankar; Ashutosh Kakkad; Narendra Chouksey; Krishnaprasad Korukonda

doi:10.18203/2320-1770.ijrcog20242810

Authors

Alpesh Gandhi Department of Obstetrics and Gynecology, Arihant Women's Hospital, Ahmedabad, Gujarat, India
Hemant Bhatt Department of Obstetrics and Gynecology, Mamta Maternity and Nursing Home, Ahmedabad, Gujarat, India
Meeta Patel Department of Obstetrics and Gynecology, Hello Mom Women’s Hospital, Ahmedabad, Gujarat, India
Prajakta Nidhankar Medical Affairs, Torrent Pharmaceuticals Limited, Ahmedabad, Gujarat, India https://orcid.org/0009-0005-5258-8138
Ashutosh Kakkad Medical Affairs, Torrent Pharmaceuticals Limited, Ahmedabad, Gujarat, India https://orcid.org/0009-0008-5821-418X
Narendra Chouksey Medical Affairs, Torrent Pharmaceuticals Limited, Ahmedabad, Gujarat, India https://orcid.org/0009-0002-5015-0413
Krishnaprasad Korukonda Medical Affairs, Torrent Pharmaceuticals Limited, Ahmedabad, Gujarat, India https://orcid.org/0000-0003-1409-0230

DOI:

https://doi.org/10.18203/2320-1770.ijrcog20242810

Keywords:

Iron deficiency anemia, Pregnancy, Micronized ferric pyrophosphate, Hemoglobin, Real-world evidence

Abstract

Background: Globally, anemia during pregnancy is a major public health concern. Conventional iron supplements limit their effectiveness due to poor absorption, water solubility and untoward GI side effects. This study assessed the clinical impact and safety of Micronized Microencapsulated Ferric Pyrophosphate (MMFP) supplementation in an antenatal setting of India.

Methods: Real world, cross-sectional, single-arm, observational study in 814 patients from 122 clinics across India. Study done with central IEC approval in accordance with ICH-GCP and Helsinki Declaration. Descriptive and analytical statistics applied for study endpoints using SPSS ver. 29.0.1.0(171).

Results: 814 pregnant women data was analysed with a mean age (29.39±3.98 years) and weight (59.48±8.14 kg). 61.79% patients were multiparous. 50.12% women were in their second trimester of pregnancy. Thyroid diseases were commonest comorbidity (21.25%). Mild anemia (37.35%) and moderate anemia (50.49%) were more prevalent. Hemoglobin levels showed significant improvement from 9.46±1.27 g/dl to 10.95±1.47 g/dl at 12 weeks (p<0.0001). Mean corpuscular volume (MCV) and serum ferritin also showed significant improvement from 85.31±9.49 fl to 90.93±8.51 fl and from 103.06±61.91 ng/ml to 164.42±79.61 ng/ml at 12 weeks (p<0.0001) respectively. Consistent improvement seen in three parameters irrespective of diet patterns or anemia severity at baseline. 12 weeks MMFP supplementation showed significant surge in patients having Hb (>11 g/dl) to 62.03% from 9.58% at baseline. Furthermore, MMFP demonstrated favourable safety profile, with only five mild adverse events observed, unrelated to the treatment.

Conclusions: MMFP supplementation is a valuable therapeutic option for managing iron deficiency anemia in pregnant women.

Metrics

Metrics Loading ...

References

Gómez-Ramírez S, Bisbe E, Shander A, Spahn DR, Muñoz M. Management of perioperative iron deficiency anemia. Acta Haematol. 2019;142(1):21-9.

Raveendran AV, Shiji P.V, Rajini P, Fathiya Suliman Al Qassabi. Iron deficiency anemia: an update. BMH Med J. 2019;6(4):116-130.

Kassebaum NJ; GBD 2013 Anemia Collaborators. The global burden of anemia. Hematol Oncol Clin North Am. 2016;30(2):247-308.

Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, et al. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013;382(9890):427‐51.

Haddad L, Hawkes C, Udomkesmalee E, Achadi E, Bendech MA, Ahuja A, Bhutta Z, De-Regil L, Fanzo J, Fracassi P, Grummer-Strawn LM. Global nutrition report 2016: from promise to impact: ending malnutrition by 2030. International Food Policy Research Institute; 2016.

Anand T, Rahi M, Sharma P, Ingle GK. Issues in prevention of iron deficiency anemia in India. Nutrition. 2014;30(7-8):764-70.

Burke RM, Leon JS, Suchdev PS. Identification, prevention and treatment of iron deficiency during the first 1000 days. Nutrients. 2014;6(10):4093-114.

Goonewardene M, Shehata M, Hamad A. Anaemia in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2012;26(1):3-24.

Api O, Breyman C, Çetiner M, Demir C, Ecder T. Diagnosis and treatment of iron deficiency anemia during pregnancy and the postpartum period: Iron deficiency anemia working group consensus report. Turk J Obstet Gynecol. 2015;12:173-81.

Manual A. Dietary guidelines for Indians. Nat Inst Nutrition. 2011;2:89-117.

Singhal SR, Kadian V, Singh S, Ghalaut VS. Comparison of various oral iron salts in the treatment of iron deficiency anemia in pregnancy. Indian J Obstetr Gynaecol Res. 2015;2(3):155-8.

Hartman-Craven B, Christofides A, O'Connor DL, Zlotkin S. Relative bioavailability of iron and folic acid from a new powdered supplement compared to a traditional tablet in pregnant women. BMC Pregn Childb. 2009;9:33.

World Health Organization. Guidelines on food fortification with micronutrients. Available at: https://www.who.int/nutrition/publications/micronutrients/GFF_Part_3_en.pdf?ua=1. Accessed on 14 May 2024.

Laganà AS, Costabile L, Filati P, Noventa M, Vitagliano A, D'Anna R. Effects of micronised dispersible ferric pyrophosphate combined with alpha-lactalbumin in pregnant women affected by iron deficiency anemia: results from a prospective, double-blind, randomized controlled trial. Eur Rev Med Pharmacol Sci. 2018;22(11):3602-8.

Swain RA, St Clair L. The role of folic acid in deficiency states and prevention of disease. J Fam Pract. 1997;44(2):138-44.

Field MS, Stover PJ. Safety of folic acid. Ann N Y Acad Sci. 2018;1414(1):59-71.

Garcia-Santos D, Schranzhofer M, Bergeron R, Sheftel AD, Ponka P. Extracellular glycine is necessary for optimal hemoglobinization of erythroid cells. Haematologica. 2017;102(8):1314-23.

Esen UI. Iron deficiency anaemia in pregnancy: The role of parenteral iron. J Obstet Gynaecol. 2017;37(1):15-8.

Centers for Disease Control and Prevention. Recommendations to prevent and control iron deficiency in the United States. MMWR Recomm Report. 1998;47:1-29.

Muñoz M, Gómez-Ramírez S, Besser M, Pavía J, Gomollón F, Liumbruno GM, et al. Current misconceptions in diagnosis and management of iron deficiency. Blood Transfus. 2017;15(5):422-37.

Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S, United States Iron Sucrose (Venofer) Clinical Trials Group. Iron Sucrose Clinical Trials G. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int 2005;68(6):2846-56.

Charytan C, Qunibi W, Bailie GR, Venofer Clinical Studies Group. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100(3):c55-62.

Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007;110(2 Part 1):267-78.

Babitt JL, Lin HY. Molecular mechanisms of hepcidin regulation: implications for the anemia of CKD. Am J Kidney Dis. 2010;55(4):726-41.

LeFevre ME, Hancock DC, Joel DD. Intestinal barrier to large particulates in mice. J Toxicol Environ Health. 1980;6(4):691-704.

Ermak TH, Dougherty EP, Bhagat HR, Kabok Z, Pappo J. Uptake and transport of copolymer biodegradable microspheres by rabbit Peyer's patch M cells. Cell Tissue Res. 1995;279(2):433-6.

World Health Organization. Anaemia. Available at: https://www.who.int/newsroom/factsheets/detail/anaemia#:~:text=During%20pregnancy%2C%20anaemia%20has%20been,%2C%20families%2C%20communities%20and%20countries. Accessed on 14 May 2024.

Kaushal S, Priya T, Thakur S, Marwaha P, Kaur H. The etiology of anemia among pregnant women in the hill state of Himachal Pradesh in North India: a cross-sectional study. Cureus. 2022;14(1):e21444.

Karami M, Chaleshgar M, Salari N, Akbari H, Mohammadi M. Global prevalence of anemia in pregnant women: a comprehensive systematic review and meta-analysis. Mater Child Heal J. 2022;26(7):1473-87.

Lin L, Wei Y, Zhu W, Wang C, Su R, Feng H, et al, Gestational diabetes mellitus Prevalence Survey (GPS) study Group. Prevalence, risk factors and associated adverse pregnancy outcomes of anaemia in Chinese pregnant women: a multicentre retrospective study. BMC Pregn Childb. 2018;18(1):1-8.

Gautam CS, Saha L, Sekhri K, Saha PK. Iron deficiency in pregnancy and the rationality of iron supplements prescribed during pregnancy. Medsc J Medi. 2008;10(12):283.

Stephen G, Mgongo M, Hussein Hashim T, Katanga J, Stray-Pedersen B, Msuya SE. Anaemia in pregnancy: prevalence, risk factors, and adverse perinatal outcomes in Northern Tanzania. Anemia. 2018:2018(1):1846280.

Yakoob MY, Bhutta ZA. Effect of routine iron supplementation with or without folic acid on anemia during pregnancy. BMC Publ Heal. 2011;11:1-0.

Ganji V, Kafai MR. Hemoglobin and hematocrit values are higher and prevalence of anemia is lower in the post–folic acid fortification period than in the pre–folic acid fortification period in US adults. Am J Clin Nutrit. 2009;89(1):363-71.

JP AK, Somannavar MS, George N. Efficacy of iron treatments on hemoglobin and ferritin levels in iron deficient pregnant women: Systematic review and meta-analysis. Clin Epidemiol Glob Heal. 2023;23:101375.