{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T04:07:11Z","timestamp":1758946031448},"reference-count":27,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2021,8,2]],"date-time":"2021-08-02T00:00:00Z","timestamp":1627862400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Obstet and Gynaecol"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>There is limited clinical evidence of ferric carboxymaltose injection (FCM) usage in Indian pregnant women. We assessed the efficacy and safety of FCM in Indian pregnant women with moderate\u2010to\u2010severe anemia.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Single\u2010center, retrospective, observational data collection was conducted at a tertiary care research institute. Data of pregnant women with anemia who received FCM in their second and third trimester was retrieved and analyzed for hematological parameters at baseline and at 4\u2009\u00b1\u20092\u2009weeks. Neonatal outcomes were also assessed. Adverse events and other safety parameters were noted.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Data of 271 patients was retrieved and analyzed for safety and data for 168 patients analyzed for efficacy. A significant increase in hemoglobin was noted with FCM in 4\u2009weeks (1.25\u2009g\/dL; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). Patients with severe anemia reported an increase in hemoglobin of 4.23\u2009g\/dL (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.01). Patients receiving FCM in the second trimester noted a significant increase in hemoglobin of 1.74\u2009g\/dL (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). A significant increase in hemoglobin was noted as early as 20\u2009days (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) and also in patients receiving FCM after 34\u2009weeks (<jats:italic>p<\/jats:italic>\u00a0=\u00a00.002). No adverse fetal or neonatal outcomes were observed. Adverse events noted in 4% of patients with itching and rash being most common. Continuous monitoring of blood pressure, heart rate, and oxygen saturation for 40\u2009min during and after FCM administration reported no deterioration or negative safety signal.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>FCM corrects anemia in all subsets of Indian pregnant women and supports evidence of efficacy and safety. Continuous monitoring of vital parameters during FCM infusions supports its excellent safety.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jog.14956","type":"journal-article","created":{"date-parts":[[2021,8,3]],"date-time":"2021-08-03T04:11:17Z","timestamp":1627963877000},"page":"3464-3470","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Clinical effects and safety of ferric carboxymaltose in pregnancy: An Indian real\u2010life experience"],"prefix":"10.1111","volume":"47","author":[{"given":"Sanjay A.","family":"Gupte","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology Gupte Hospital and Centre for Research in Reproduction  Pune India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gayatri","family":"Venkataraman","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Gupte Hospital and Centre for Research in Reproduction  Pune India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aarti S.","family":"Shah","sequence":"additional","affiliation":[{"name":"Pulse Clinic  Ahmedabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aparna S.","family":"Mudholkar","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Gupte Hospital and Centre for Research in Reproduction  Pune India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shweta M.","family":"Jangam","sequence":"additional","affiliation":[{"name":"Department of Clinical Research Gupte Hospital and Centre for Research in Reproduction  Pune India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,8,2]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"World Health Organization.Vitamin and Mineral Nutrition Information System (VMNIS) Worldwide prevalence on anaemia 1993\u20132005 Summary of the worldwide prevalence on anaemia. Available from:https:\/\/www.who.int\/vmnis\/database\/anaemia\/anaemia_status_summary\/en\/. Accessed 03 Jan 2021."},{"key":"e_1_2_8_3_1","unstructured":"National Family Health Survey Key findings from NFHS\u20105. Available from:http:\/\/rchiips.org\/nfhs\/factsheet_NFHS-5.shtmlAccessed 03 Jan 2021."},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12884-019-2200-3"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.nut.2013.11.022"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.seminhematol.2015.07.003"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12288-018-0949-6"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(19)30427-9"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-018-0885-7"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1515\/jpm-2011-0231"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1258\/om.2012.110095"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1155\/2015\/728952"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2393-14-115"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1155\/2016\/5060252"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1515\/jpm-2016-0050"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12884-018-1817-y"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-018-4782-9"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.seminhematol.2018.04.006"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1155\/2019\/4640635"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-020-05817-7"},{"key":"e_1_2_8_21_1","unstructured":"WHO.Vitamin andMineral Nutrition Information System. Haemoglobin concentrations for the diagnosis ofanaemia and assessment of severity (WHO\/NMH\/NHD\/MNM\/11.1). Available from:http:\/\/www.who.int\/vmnis\/indicators\/haemoglobin.pdf. Accessed 15 June 2021."},{"key":"e_1_2_8_22_1","unstructured":"Orofer FCM [package insert]. Pune India: Emcure Pharmaceuticals Ltd.2017."},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/hdi.12560"},{"issue":"6","key":"e_1_2_8_24_1","first-page":"399","article-title":"The efficacy and safety of current intravenous iron preparations for the management of iron\u2010deficiency anaemia: a review","volume":"60","author":"Qunibi WY","year":"2010","journal-title":"Arzneimittelforschung"},{"key":"e_1_2_8_25_1","unstructured":"AnemiaMukt Bharat.Anemia management protocol for pregnant women. Available from:https:\/\/anemiamuktbharat.info\/home\/interventions. 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