{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T06:16:10Z","timestamp":1770272170343,"version":"3.49.0"},"reference-count":35,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,1,18]],"date-time":"2023-01-18T00:00:00Z","timestamp":1674000000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100018036","name":"Nippon Shinyaku","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100018036","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Obstet and Gynaecol"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>Single\u2010arm, open\u2010label, phase 3 study to evaluate the efficacy and safety of ferric derisomaltose (FDI) for iron deficiency anemia (IDA) in Japanese women with postpartum hemorrhage (PPH).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Postpartum women aged 20\u201339\u2009years with serum ferritin &lt;25.0\u00a0ng\/ml, hemoglobin (Hb) &lt;10.0\u00a0g\/dl, and blood loss \u2265500\u2009ml within 24\u2009h post\u2010delivery were eligible to receive high\u2010dose intravenous FDI. The primary endpoint was the maximum change in Hb concentration by Week 8. Key secondary endpoints included change in iron parameters and percentage of patients with a total Edinburgh Postnatal Depression Score (EPDS) \u22659. Safety assessments included treatment\u2010emergent adverse events (TEAEs) and iron concentrations in maternal milk.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>All (<jats:italic>n<\/jats:italic>\u00a0=\u200921 [100.0%]) patients received the predetermined total iron dose by Day 8. Hb concentrations increased rapidly and significantly (<jats:italic>p<\/jats:italic>\u00a0&lt;\u20090.001) following FDI. Serum ferritin levels also increased rapidly and were maintained near or above the upper limit of normal reference value (250\u2009ng\/ml). Following FDI, two (9.5%) patients had a total EPDS score of \u22659. TEAEs occurred in 23 of 42 (54.8%) patients and neonates overall, including 18 of 21 (85.7%) patients and 5 of 21 (23.8%) neonates. TEAEs were mild in all adult patients and four neonates, and moderate in one neonate. Iron concentrations in maternal milk remained within normal reference values. Appropriate patient selection and patient\u2010adjusted dosage selection facilitated safe and effective administration of high\u2010dose (\u22651000\u2009mg) FDI.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Rapid and sustained improvements in Hb and iron stores occurred following FDI for IDA with PPH, with no new safety signals identified.<\/jats:p><jats:p><jats:italic>Clinical trial identifier<\/jats:italic>: JapicCTI\u2010194888.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jog.15546","type":"journal-article","created":{"date-parts":[[2023,1,19]],"date-time":"2023-01-19T03:06:22Z","timestamp":1674097582000},"page":"946-955","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Ferric derisomaltose for the treatment of iron deficiency anemia with postpartum hemorrhage: Results of a single\u2010arm, open\u2010label, phase 3 study in Japan"],"prefix":"10.1111","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2122-3719","authenticated-orcid":false,"given":"Motoi","family":"Sugimura","sequence":"first","affiliation":[{"name":"Department of Obstetrics, Gynecology and Family Medicine Hamamatsu University School of Medicine  Hamamatsu Shizuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuyoshi","family":"Ohtani","sequence":"additional","affiliation":[{"name":"Research and Development Administration Department Nippon Shinyaku Co. Ltd.  Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soichiro","family":"Tamai","sequence":"additional","affiliation":[{"name":"Clinical Development Division, Data Science Department Nippon Shinyaku Co. Ltd.  Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Umi","family":"Kishimoto","sequence":"additional","affiliation":[{"name":"Clinical Development Division, Clinical Development Department Nippon Shinyaku Co. Ltd.  Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoki","family":"Ito","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Teikyo University School of Medicine  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,1,18]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hoc.2015.11.002"},{"key":"e_1_2_10_3_1","unstructured":"World Health Organization (WHO).WHO Global Anaemia estimates 2021 Edition. [cited Dec 7 2021]. Available from:https:\/\/www.who.int\/data\/gho\/data\/themes\/topics\/anaemia_in_women_and_children."},{"key":"e_1_2_10_4_1","unstructured":"World Health Organization.WHO recommendations for the prevention and treatment of postpartum haemorrhage. [Cited: Dec 9 2021.]. 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