{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T18:30:35Z","timestamp":1740162635197,"version":"3.37.3"},"reference-count":20,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T00:00:00Z","timestamp":1625011200000},"content-version":"unspecified","delay-in-days":29,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Department of Health and Research, Ministry of Health and Family Welfare","award":["T.11011\/12\/2019-HR\/E-Office- 3207453"],"award-info":[{"award-number":["T.11011\/12\/2019-HR\/E-Office- 3207453"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,6,2]]},"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Maternal anaemia is a major public health issue in India. The government of India recommends parenteral iron to manage moderate and severe grades of anaemia. In contrast to its clinical efficacy, the cost-effectiveness of intravenous iron sucrose and ferric carboxymaltose is not yet established in Indian context. This article illustrates the protocol of health technology assessment to evaluate the cost-effectiveness of intravenous therapy on the improvement of haemoglobin concentration over oral therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>The study will be carried out in two districts of Gujarat state. The study participants will be selected by a proportionate sampling method from the rural, tribal, desert and coastal region of the districts. Data will be collected over 1\u2009year on key outcome indicators using a mixed-method approach. Key informant interviews will be conducted, and cost data will be gathered to perform cost-effectiveness analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>This study is approved by the Technical Appraisal Committee of Health Technology Assessment India, Department of Health Research and Institutional Ethics Committee of the Indian Institute of Public Health, Gandhinagar.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2020-044712","type":"journal-article","created":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T16:35:06Z","timestamp":1625070906000},"page":"e044712","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Protocol for the cost-effectiveness of parenteral iron and oral iron therapy for first-line management of anaemia among pregnant women in a natural programme setting in Gujarat"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8043-3388","authenticated-orcid":false,"given":"Somen","family":"Saha","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1978-547X","authenticated-orcid":false,"given":"Bharat","family":"Desai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manish","family":"Fancy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tapasvi","family":"Puwar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deepak","family":"Saxena","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Komal","family":"Shah","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0178-3978","authenticated-orcid":false,"given":"Apurvakumar","family":"Pandya","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,6,30]]},"reference":[{"key":"2024112411562777000_11.6.e044712.1","doi-asserted-by":"crossref","first-page":"100098","DOI":"10.1016\/j.onehlt.2019.100098","article-title":"Maternal and severe anaemia in delivering women is associated with risk of preterm and low birth weight: a cross sectional study from Jharkhand, India","volume":"8","author":"Kumari","year":"2019","journal-title":"One Health"},{"key":"2024112411562777000_11.6.e044712.2","first-page":"7","article-title":"Hematological study of iron deficiency anaemia in pregnancy in central Gujarat","volume":"10","author":"Jasani","year":"2019","journal-title":"Int J Biomed Adv Res"},{"key":"2024112411562777000_11.6.e044712.3","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0117383","article-title":"Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis","volume":"10","author":"Tolkien","year":"2015","journal-title":"PLoS One"},{"key":"2024112411562777000_11.6.e044712.4","first-page":"270","article-title":"Study of anaemia in pregnancy and its outcome in Nepal medical college teaching Hospital, Kathmandu, Nepal","volume":"9","author":"Marahatta","year":"2007","journal-title":"Nepal Med Coll J"},{"key":"2024112411562777000_11.6.e044712.5","first-page":"627","article-title":"Prevalence & consequences of anaemia in pregnancy","volume":"130","author":"Kalaivani","year":"2009","journal-title":"Indian J Med Res"},{"key":"2024112411562777000_11.6.e044712.6","first-page":"78","article-title":"Intravenous iron sucrose therapy for moderate to severe anaemia in pregnancy","volume":"138","author":"Kriplani","year":"2013","journal-title":"Indian J Med Res"},{"key":"2024112411562777000_11.6.e044712.7","doi-asserted-by":"crossref","first-page":"e1706","DOI":"10.1016\/S2214-109X(19)30427-9","article-title":"Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial","volume":"7","author":"Neogi","year":"2019","journal-title":"Lancet Glob Health"},{"key":"2024112411562777000_11.6.e044712.8","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1111\/ajo.12695","article-title":"Safety and efficacy of intravenous iron polymaltose, iron sucrose and ferric carboxymaltose in pregnancy: a systematic review","volume":"58","author":"Qassim","year":"2018","journal-title":"Aust N Z J Obstet Gynaecol"},{"key":"2024112411562777000_11.6.e044712.9","doi-asserted-by":"crossref","first-page":"544","DOI":"10.5455\/2320-1770.ijrcog20131211","article-title":"Is it safe to use intravenous iron sucrose during pregnancy? A randomized controlled trial","volume":"2","author":"Dubey","year":"2013","journal-title":"Int J Reprod Contracept Obstet Gynecol"},{"key":"2024112411562777000_11.6.e044712.10","doi-asserted-by":"crossref","first-page":"25","DOI":"10.4103\/2229-516X.149230","article-title":"Ferric carboxymaltose: a revolution in the treatment of postpartum anemia in Indian women","volume":"5","author":"Rathod","year":"2015","journal-title":"Int J Appl Basic Med Res"},{"doi-asserted-by":"publisher","key":"2024112411562777000_11.6.e044712.11","DOI":"10.1155\/2012\/179827"},{"unstructured":"Ministry of Women and Child Development Department, Government of India . Jan Andolan guidelines- Poshan Abhiyan, 2019.","key":"2024112411562777000_11.6.e044712.12"},{"unstructured":"Ministry of Health and Family Welfare, Government of India . Intensified national iron plus initiative (I-NIPI): operational guidelines for programme managers, 2018.","key":"2024112411562777000_11.6.e044712.13"},{"key":"2024112411562777000_11.6.e044712.14","doi-asserted-by":"crossref","DOI":"10.1186\/s12884-019-2200-3","article-title":"Comparison of ferric carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial","volume":"19","author":"Jose","year":"2019","journal-title":"BMC Pregnancy Childbirth"},{"doi-asserted-by":"publisher","key":"2024112411562777000_11.6.e044712.15","DOI":"10.4103\/0970-0218.103467"},{"key":"2024112411562777000_11.6.e044712.16","first-page":"301","article-title":"[Intravenous iron-dextran: therapeutic and experimental possibilities]","volume":"100","author":"Ganzoni","year":"1970","journal-title":"Schweiz Med Wochenschr"},{"unstructured":"Ezzati M , Lopez AD , Rodgers AA . Comparative quantification of health risks: global and regional burden of disease attributable to selected major risk factors, 2004.","key":"2024112411562777000_11.6.e044712.17"},{"key":"2024112411562777000_11.6.e044712.18","doi-asserted-by":"crossref","first-page":"165","DOI":"10.4103\/ijph.IJPH_409_19","article-title":"Do we have a magic bullet to treat moderate and severe anemia in pregnant women?","volume":"63","author":"Kant","year":"2019","journal-title":"Indian J Public Health"},{"key":"2024112411562777000_11.6.e044712.19","first-page":"96","article-title":"Evaluation of efficacy, safety and cost-effectiveness of oral iron and injectable iron sucrose and ferric carboxy maltose in pregnant women in 2nd and 3rd trimester in anaemia","volume":"4","author":"Maheshwari","year":"2017","journal-title":"Indian J Obs Gynecol Res"},{"key":"2024112411562777000_11.6.e044712.20","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1016\/j.ijgo.2015.09.007","article-title":"Randomized controlled trial comparing ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia due to abnormal uterine bleeding","volume":"133","author":"Mahey","year":"2016","journal-title":"Int J Gynaecol Obstet"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-044712","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,24]],"date-time":"2024-11-24T19:58:57Z","timestamp":1732478337000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-044712"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6]]},"references-count":20,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2021,6,30]]},"published-print":{"date-parts":[[2021,6]]}},"alternative-id":["10.1136\/bmjopen-2020-044712"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-044712","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2021,6]]}}}