{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T06:13:46Z","timestamp":1789020826976,"version":"build-2803163510"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2022,9,15]],"date-time":"2022-09-15T00:00:00Z","timestamp":1663200000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,9,15]],"date-time":"2022-09-15T00:00:00Z","timestamp":1663200000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Pharmacosmos A\/S"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Arch Gynecol Obstet"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>To compare the efficacy of intravenous (IV) iron (ferric derisomaltose) with oral iron\u00a0(ferrous fumarate) in women 14\u201321 weeks pregnant with persistent iron deficiency (ferritin\u2009&lt;\u200930\u00a0\u00b5g\/L).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In a single-centre, open-label, randomised controlled trial at a Danish hospital, women with persistent iron deficiency after routine oral iron treatment were allocated to receive 1000\u00a0mg IV iron (single-dose) or 100\u00a0mg elemental oral iron daily. Outcomes were assessed during an 18-week follow-up period. The primary endpoint was the proportion of non-anaemic (haemoglobin [Hb]\u2009\u2265\u200911\u00a0g\/dL) women throughout follow-up. Other outcomes included changes in haematological parameters, patient-reported fatigue, and quality of life (QoL). Safety was assessed by recording adverse events.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>From July 2017 to February 2020, 100 women were randomised to IV iron and 101 to oral iron. Throughout follow-up, 91% of women were non-anaemic in the IV iron group compared with 73% in the oral iron group (18% difference [95% confidence interval 0.10\u20130.25]; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). The mean Hb increase was significantly greater with IV iron versus oral iron at Weeks 6 (0.4 versus \u2212\u00a00.2\u00a0g\/dL; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), 12 (0.5 versus 0.1\u00a0g\/dL; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), and 18 (0.8 versus 0.5\u00a0g\/dL; <jats:italic>p<\/jats:italic>\u2009=\u20090.01). Improvements in fatigue and QoL were greater with IV iron versus oral iron at Weeks 3 and 6. The incidence of treatment-related adverse events was comparable between treatment groups.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>IV iron was superior in preventing anaemia compared with oral iron in pregnant women with persistent iron deficiency; biochemical superiority was accompanied by improved fatigue and QoL.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Clinical trial registration<\/jats:title>\n                <jats:p>European Clinical Trials Database: EudraCT no.: 2017-000776-29 (3 May 2017); ClinicalTrials.gov: NCT03188445 (13 June 2017).<\/jats:p>\n                <jats:p>The trial protocol has been published: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/dx.doi.org\/10.1186%2Fs13063-020-04637-z\">https:\/\/dx.doi.org\/10.1186%2Fs13063-020-04637-z<\/jats:ext-link>.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00404-022-06768-x","type":"journal-article","created":{"date-parts":[[2022,9,15]],"date-time":"2022-09-15T12:08:10Z","timestamp":1663243690000},"page":"1165-1173","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial"],"prefix":"10.1007","volume":"308","author":[{"given":"Rebecka","family":"Hansen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veronika Markova","family":"Sommer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anja","family":"Pinborg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lone","family":"Krebs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars Lykke","family":"Thomsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Torben","family":"Moos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2278-2384","authenticated-orcid":false,"given":"Charlotte","family":"Holm","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,9,15]]},"reference":[{"key":"6768_CR1","volume-title":"The global prevalence of anaemia in 2011","author":"World Health Organization","year":"2015","unstructured":"World Health Organization (2015) The global prevalence of anaemia in 2011. 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The sponsor was involved in the study design, analysis and interpretation of the data, and approval of the final manuscript. Charlotte Holm was the primary investigator of the trial. Lars Lykke Thomsen is employed by Pharmacosmos A\/S, as was Veronika Markova Sommer during the trial. Rebecka Hansen was employed by the institution with salary costs funded by Pharmacosmos A\/S. Charlotte Holm and Rebecka Hansen have served on advisory boards for Pharmacosmos A\/S. Charlotte Holm has received speaker honoraria from Pharmacosmos A\/S. The remaining authors have no conflicts of interest to declare.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The trial was approved by the Danish Medicines Agency and the Danish Scientific Ethics Committees (H-17005699) and registered in the European Clinical Trials Database (EudraCT no.: 2017\u2013000776-29) and on ClinicalTrials.gov (NCT03188445). The authorities approved the study protocol in May 2017 and further amendments in November 2017 (key changes: inclusion criteria of iron deficiency anaemia changed to both non-anaemic and anaemic iron deficiency, and the upper gestational time window changed from 16\u2009+\u20090 to 19\u2009+\u20090\u00a0weeks). The first randomisation was performed in December 2017; hence, these first amendments were approved before the randomisation of any participants. Additional amendments were approved in July 2018 (key change: upper gestational age time window changed from 19\u2009+\u20090 to 21\u2009+\u20090\u00a0weeks) and September 2019 (key changes: adding hypophosphatemia as a secondary endpoint and including a detailed definition of obstetric and perinatal endpoints).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Written informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}]}}