{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T06:26:12Z","timestamp":1792650372065,"version":"4.5.0"},"reference-count":25,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2024,8,14]],"date-time":"2024-08-14T00:00:00Z","timestamp":1723593600000},"content-version":"unspecified","delay-in-days":13,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["INV - 032911"],"award-info":[{"award-number":["INV - 032911"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,7,30]]},"published-print":{"date-parts":[[2024,8]]},"abstract":"\n Introduction<\/jats:title>\n Postpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50\u201380% in low-income and middle-income countries. It poses adverse consequences on the mother and negatively impacts her ability to care for her newborn. Prompt treatment of postpartum anaemia is thus important. Adherence to oral iron is reportedly low in Nigeria due to its side effects and forgetfulness by the mothers. Intravenous iron such as ferric carboxymaltose, given as a single dose, might help overcome adherence issues, but investigation in a high-quality randomised control trial in Nigeria is first required while evaluation of challenges around its implementation is also warranted.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To determine the clinical effectiveness, tolerability and safety, of using intravenous ferric carboxymaltose (intervention) vs oral ferrous sulphate (control) for treating moderate to severe iron deficiency anaemia in postpartum women and to evaluate implementation of ferric carboxymaltose in treating postpartum anaemia in Nigeria.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n This study is an open-label randomised controlled trial with a concurrent implementation study. It is a hybrid type 1 effectiveness-implementation design conducted in four states across Northern and Southern Nigeria. A total of 1400 eligible and consenting women with postpartum moderate to severe anaemia (haemoglobin concentration <100\u2009g\/L) will be randomised to intravenous ferric carboxymaltose; a single dose at 20\u2009mg\/kg to a maximum of 1000\u2009mg infusion administered at enrolment (intervention) or oral ferrous sulphate; 200\u2009mg (65\u2009mg elemental iron) two times per day from enrolment until 6 weeks postpartum (control). The primary outcome, proportion of participants who are anaemic (Hb <110 g\/L) at 6\u2009weeks postpartum will be analysed by intention-to-treat. Haemoglobin concentration, full blood count, serum iron, serum ferritin, transferrin saturation and total iron binding capacity will be measured at specific intervals. Implementation outcomes such as acceptability and feasibility of using ferric carboxymaltose for postpartum anaemia treatment in Nigeria will be assessed.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n This study is approved by the ethics committee of the teaching hospitals, Ministry of Health of the four states as required, National Health Research Ethics Committee and the drug regulatory agency, National Agency for Food and Drug Administration and Control (NAFDAC). Findings of this research will be presented at conferences and will be published in international peer-reviewed journals and shared with stakeholders within and outside Nigeria.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n International standard randomised controlled trial number:\n ISRCTN51426226<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-086553","type":"journal-article","created":{"date-parts":[[2024,8,17]],"date-time":"2024-08-17T06:12:28Z","timestamp":1723875148000},"page":"e086553","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":10,"title":["Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women (IVON-PP): protocol for an open-label randomised controlled type 1 hybrid effectiveness-implementation trial"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"isrctn51426226","registry":"10.18810\/isrctn"},{"clinical-trial-number":"isrctn51426226","registry":"10.18810\/isrctn"},{"clinical-trial-number":"isrctn51426226","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7511-7567","authenticated-orcid":false,"given":"Bosede Bukola","family":"Afolabi","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynaecology, University of Lagos College of Medicine, Lagos, Nigeria"},{"name":"Department of Obstetrics and Gynaecology, Lagos University Teaching Hospital, Surulere, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria Olawunmi","family":"Adaramoye","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, University of Lagos College of Medicine, Lagos, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Titilope Adenike","family":"Adeyemo","sequence":"additional","affiliation":[{"name":"Department of Hematology & Blood Transfusion, University of Lagos College of Medicine, Lagos, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8147-2111","authenticated-orcid":false,"given":"Mobolanle","family":"Balogun","sequence":"additional","affiliation":[{"name":"Department of Community Health & Primary Care, University of Lagos, Mushin, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6998-4533","authenticated-orcid":false,"given":"Eleanor J","family":"Mitchell","sequence":"additional","affiliation":[{"name":"Nottingham Clinical Trials Unit, University of Nottingham Faculty of Medicine and Health Sciences, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate","family":"Walker","sequence":"additional","affiliation":[{"name":"University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Opeyemi Rebecca","family":"Akinajo","sequence":"additional","affiliation":[{"name":"Lagos University Teaching Hospital, Surulere, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibraheem Ajibola","family":"Abioye","sequence":"additional","affiliation":[{"name":"Department of Global Health and Population, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aduragbemi","family":"Banke-Thomas","sequence":"additional","affiliation":[{"name":"Maternal Adolescent Reproductive and Child Health Centre, London School of Hygiene & Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ochuwa Adiketu","family":"Babah","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, University of Lagos College of Medicine, Lagos, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chisom Florence","family":"Chieme","sequence":"additional","affiliation":[{"name":"Centre for Clinical Trials, Research, and Implementation Science, College of Medicine, University of Lagos\/ Lagos University Teaching Hospital, Idi-araba, Lagos, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yewande","family":"Oshodi","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, University of Lagos College of Medicine, Lagos, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Quao","sequence":"additional","affiliation":[{"name":"Centre for Clinical Trials, Research, and Implementation Science, College of Medicine, University of Lagos\/ Lagos University Teaching Hospital, Idi-araba, Lagos, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ejemai Amaize","family":"Eboreime","sequence":"additional","affiliation":[{"name":"Department of Planning, Research & Statistics, NPHCDA, Abuja, Nigeria"},{"name":"Department of Psychiatry, University of Alberta Faculty of Medicine and Dentistry, Edmonton, Alberta, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Folasade","family":"Ogunsola","sequence":"additional","affiliation":[{"name":"Department of Microbiology, College of Medicine, University of Lagos\/Lagos University Teaching Hospital, Akoka, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,8,17]]},"reference":[{"key":"2025121509563720000_14.8.e086553.1","doi-asserted-by":"crossref","DOI":"10.1186\/s43058-023-00400-y","article-title":"A continuous quality improvement strategy to strengthen screening practices and facilitate the routine use of intravenous iron for treating anaemia in pregnant and postpartum women in Nigeria: A study protocol","volume":"4","author":"Eboreime","year":"2023","journal-title":"Impl Sci Commun"},{"key":"2025121509563720000_14.8.e086553.2","doi-asserted-by":"crossref","first-page":"3648","DOI":"10.1017\/S1368980020004620","article-title":"Spatio-temporal trends in anaemia among pregnant women, adolescents and preschool children in sub-Saharan Africa","volume":"24","author":"Weze","year":"2021","journal-title":"Public Health Nutr"},{"key":"2025121509563720000_14.8.e086553.3","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0263501","article-title":"Prevalence of post-partum anemia and associated factors among women attending public primary health care facilities: an institutional based cross-sectional study","volume":"17","author":"Mremi","year":"2022","journal-title":"PLoS One"},{"key":"2025121509563720000_14.8.e086553.4","doi-asserted-by":"crossref","DOI":"10.1186\/s12889-022-12710-2","article-title":"Effect of postpartum anaemia on maternal health-related quality of life: a systematic review and meta-analysis","volume":"22","author":"Moya","year":"2022","journal-title":"BMC Public Health"},{"key":"2025121509563720000_14.8.e086553.5","doi-asserted-by":"crossref","first-page":"709","DOI":"10.4103\/1119-3077.178912","article-title":"Rates and determinants of peripartum and puerperal anemia in Enugu, Nigeria","volume":"19","author":"Emegoakor","year":"2016","journal-title":"Niger J Clin Pract"},{"key":"2025121509563720000_14.8.e086553.6","first-page":"115","article-title":"The association between anemia and postpartum depression: A systematic review and meta-analysis","volume":"10","author":"Azami","year":"2019","journal-title":"Caspian J Intern Med"},{"key":"2025121509563720000_14.8.e086553.7","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1111\/j.1523-536X.1995.tb00565.x","article-title":"Anemia and insufficient milk in first-time mothers","volume":"22","author":"Henly","year":"1995","journal-title":"Birth"},{"key":"2025121509563720000_14.8.e086553.8","doi-asserted-by":"crossref","first-page":"e342","DOI":"10.1016\/S2352-3026(19)30264-9","article-title":"Intravenous iron: a framework for changing the management of iron deficiency","volume":"7","author":"Auerbach","year":"2020","journal-title":"Lancet Haematol"},{"key":"2025121509563720000_14.8.e086553.9","doi-asserted-by":"crossref","DOI":"10.11604\/pamj.2019.34.211.16446","article-title":"Assessment of adherence to iron supplementation among pregnant women in the Yaounde gynaeco-obstetric and paediatric hospital","volume":"34","author":"Fouelifack","year":"2019","journal-title":"Pan Afr Med J"},{"key":"2025121509563720000_14.8.e086553.10","doi-asserted-by":"publisher","DOI":"10.3945\/jn.115.225482"},{"key":"2025121509563720000_14.8.e086553.11","doi-asserted-by":"crossref","unstructured":"Ba DM , Ssentongo P , Kjerulff KH , et al . Adherence to iron supplementation in 22 sub-Saharan African countries and associated factors among pregnant women: a large population-based study. Curr Dev Nutr 2019;3.","DOI":"10.1093\/cdn\/nzz120"},{"key":"2025121509563720000_14.8.e086553.12","doi-asserted-by":"crossref","first-page":"654","DOI":"10.3109\/14767058.2012.746299","article-title":"Intravenous iron sucrose versus oral iron ferrous sulfate for antenatal and postpartum iron deficiency anemia: a randomized trial","volume":"26","author":"Froessler","year":"2013","journal-title":"J Matern Fetal Neonatal Med"},{"key":"2025121509563720000_14.8.e086553.13","first-page":"S83","article-title":"The available intravenous iron formulations: History, efficacy, and toxicology","volume":"21 Suppl 1","author":"Auerbach","year":"2017","journal-title":"Hemodial Int"},{"key":"2025121509563720000_14.8.e086553.14","doi-asserted-by":"crossref","DOI":"10.1016\/j.psychres.2019.112630","article-title":"Reprint of: An introduction to effectiveness-implementation hybrid designs","volume":"283","author":"Landes","year":"2020","journal-title":"Psychiatry Res"},{"key":"2025121509563720000_14.8.e086553.15","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.150.6.782"},{"key":"2025121509563720000_14.8.e086553.16","doi-asserted-by":"crossref","first-page":"471","DOI":"10.1007\/s00737-018-0818-1","article-title":"Postpartum fatigue: assessing and improving the psychometric properties of the fatigue severity scale","volume":"21","author":"Wilson","year":"2018","journal-title":"Arch Womens Ment Health"},{"key":"2025121509563720000_14.8.e086553.17","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1007\/s00737-006-0132-1","article-title":"The postpartum bonding questionnaire: a validation","volume":"9","author":"Brockington","year":"2006","journal-title":"Arch Womens Ment Health"},{"key":"2025121509563720000_14.8.e086553.18","doi-asserted-by":"publisher","DOI":"10.1017\/S0033291798006667"},{"key":"2025121509563720000_14.8.e086553.19","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1016\/j.ajog.2018.12.016","article-title":"Oral vs intravenous iron therapy for postpartum anemia: a systematic review and meta-analysis","volume":"221","author":"Sultan","year":"2019","journal-title":"Am J Obstet Gynecol"},{"key":"2025121509563720000_14.8.e086553.20","unstructured":"RStudio: integrated development for R rstudio. Boston, MA Available: http:\/\/www.rstudio.com"},{"key":"2025121509563720000_14.8.e086553.21","doi-asserted-by":"publisher","DOI":"10.2307\/2530245"},{"key":"2025121509563720000_14.8.e086553.22","unstructured":"ResearchTeam C . n.d. consolidated framework for Implementation Research interview guide tool."},{"key":"2025121509563720000_14.8.e086553.23","first-page":"53","article-title":"Making sense of implementation theories, models, and frameworks","volume":"3","author":"Nilsen","year":"2020","journal-title":"Impl Sci"},{"key":"2025121509563720000_14.8.e086553.24","doi-asserted-by":"publisher","DOI":"10.1080\/0142159X.2018.1497149"},{"key":"2025121509563720000_14.8.e086553.25","doi-asserted-by":"crossref","DOI":"10.1186\/s13012-017-0635-3","article-title":"Psychometric assessment of three newly developed implementation outcome measures","volume":"12","author":"Weiner","year":"2017","journal-title":"Impl Sci"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2024-086553","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T17:56:44Z","timestamp":1765821404000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2024-086553"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8]]},"references-count":25,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2024,8,17]]},"published-print":{"date-parts":[[2024,8]]}},"alternative-id":["10.1136\/bmjopen-2024-086553"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2024-086553","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8]]}}}