دورية أكاديمية
Protocol and statistical analysis plan for a randomized controlled trial of the effect of intravenous iron on anemia in Malawian pregnant women in their third trimester (REVAMP - TT).
العنوان: | Protocol and statistical analysis plan for a randomized controlled trial of the effect of intravenous iron on anemia in Malawian pregnant women in their third trimester (REVAMP - TT). |
---|---|
المؤلفون: | Harding R; Population Health and Immunity, Walter and Eliza Hall Institute of Medical Research, Parkville, Vic, 3052, Australia., Moya E; Training and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi.; Department of Public Health, Kamuzu University of Health Sciences, School of Global and Public Health, Private Bag 360, Chichiri, Blantyre, BT3, Malawi., Ataíde R; Population Health and Immunity, Walter and Eliza Hall Institute of Medical Research, Parkville, Vic, 3052, Australia.; Infectious Diseases, Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, 3000, Australia., Truwah Z; Training and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi., Mzembe G; Training and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi.; Department of Public Health, Kamuzu University of Health Sciences, School of Global and Public Health, Private Bag 360, Chichiri, Blantyre, BT3, Malawi., Mhango G; Training and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi., Demir AV; Meander Medical Center, Laboratory for Clinical Chemistry, Maatweg 3, Amersfoort, 3813 TZ, The Netherlands., Stones W; Centre for Reproductive Health, Kamuzu University of Health Sciences, Private Bag 360, Chichiri, Blantyre, BT3, Malawi., Randall L; Population Health and Immunity, Walter and Eliza Hall Institute of Medical Research, Parkville, Vic, 3052, Australia., Seal M; Developmental Imaging, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia., Johnson K; Melbourne School of Psychological Sciences, The University of Melbourne, Melbourne, Victoria, 3010, Australia., Bode S; Melbourne School of Psychological Sciences, The University of Melbourne, Melbourne, Victoria, 3010, Australia., Mwangi MN; Training and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi.; The Micronutrient Forum, Washington DC, 20005-5905, USA., Pasricha SR; Population Health and Immunity, Walter and Eliza Hall Institute of Medical Research, Parkville, Vic, 3052, Australia.; Diagnostic Haematology and Clinical Haematology, The Peter MacCallum Cancer Centre, The Royal Melbourne Hospital, Parkville, Victoria, 3052, Australia., Braat S; Population Health and Immunity, Walter and Eliza Hall Institute of Medical Research, Parkville, Vic, 3052, Australia.; Centre for Epidemiology and Biostatistics, School of Population and Global Health,, The University of Melbourne, Melbourne, Victoria, 3000, Australia., Phiri KS; Training and Research Unit of Excellence (TRUE), 1 Kufa Road, P.O. Box 30538, Chichiri, Blantyre, BT3, Malawi.; Department of Public Health, Kamuzu University of Health Sciences, School of Global and Public Health, Private Bag 360, Chichiri, Blantyre, BT3, Malawi. |
المصدر: | Gates open research [Gates Open Res] 2023 Dec 18; Vol. 7, pp. 117. Date of Electronic Publication: 2023 Dec 18 (Print Publication: 2023). |
نوع المنشور: | Clinical Trial Protocol; Journal Article |
اللغة: | English |
بيانات الدورية: | Publisher: Bill and Melinda Gates Foundation Country of Publication: United States NLM ID: 101717821 Publication Model: eCollection Cited Medium: Internet ISSN: 2572-4754 (Electronic) Linking ISSN: 25724754 NLM ISO Abbreviation: Gates Open Res Subsets: MEDLINE |
أسماء مطبوعة: | Original Publication: Seattle, WA : Bill and Melinda Gates Foundation, [2017]- |
مواضيع طبية MeSH: | Anemia, Iron-Deficiency*/drug therapy , Anemia*/drug therapy , Ferric Compounds*, Maltose/*analogs & derivatives, Infant, Newborn ; Child ; Female ; Humans ; Pregnancy ; Iron/therapeutic use ; Pregnancy Trimester, Third ; Pregnant Women ; Hemoglobins/analysis ; Malawi/epidemiology ; Randomized Controlled Trials as Topic |
مستخلص: | Background: Anemia affects 40% of pregnant women globally, leading to maternal mortality, premature birth, low birth weight, and poor baby development. Iron deficiency causes over 40% of anemia cases in Africa. Oral iron supplementation is insufficient for Low-and-Middle-Income-Countries (LMICs) to meet current WHO targets. We hypothesized that a single intravenous dose of Ferric Carboxymaltose (FCM) may be more effective than oral iron treatment for anemia recovery, particularly in these settings where women present late for antenatal care. Methods: This is a two-arm parallel open-label individual-randomized controlled trial in third trimester, in malaria Rapid Diagnostic Test-negative pregnant women with moderate or severe anemia - capillary hemoglobin <10 g/dL - who are randomized to receive either parenteral iron - with FCM - or standard-of-care oral iron for the remainder of pregnancy. This is the sister trial to the second-trimester REVAMP trial, funded by the Bill and Melinda Gates Foundation (trial registration ACTRN12618001268235, Gates Grant number INV-010612). In REVAMP-TT, recruitment and treatment are performed within primary health centers. The trial will recruit 590 women across Zomba district, Malawi. The primary outcome is the proportion of anemic women - venous hemoglobin <11 g/dL - at 36 weeks' gestation or delivery (whichever occurs first). Other pre-specified key secondary clinical and safety outcomes include maternal iron-status and hypophosphatemia, neonate birth weight, infant growth and infant iron and hematological parameters. Discussion: This study will determine whether FCM, delivered within primary health centers, is effective, safe and feasible for treating moderate to severe anemia in third-trimester pregnant Malawian women. This intervention could have long-term benefits for maternal and child health, resulting in improved survival and child development. Competing Interests: No competing interests were disclosed. (Copyright: © 2023 Harding R et al.) |
References: | J Nutr. 2017 Jun;147(6):1131-1137. (PMID: 28424258) J Perinat Med. 2017 May 24;45(4):443-453. (PMID: 27278921) JAMA. 2015 Sep 8;314(10):1009-20. (PMID: 26348751) Cochrane Database Syst Rev. 2016 Apr 18;4:CD009747. (PMID: 27087396) Stat Med. 2011 Dec 10;30(28):3267-84. (PMID: 22105690) Lancet. 2023 May 13;401(10388):1595-1609. (PMID: 37088092) Trials. 2017 Apr 8;18(1):169. (PMID: 28388937) Implement Sci Commun. 2022 Jun 21;3(1):68. (PMID: 35729604) N Engl J Med. 2021 Sep 9;385(11):982-995. (PMID: 34496174) Expert Rev Hematol. 2019 Feb;12(2):129-136. (PMID: 30689458) Med J Aust. 2019 Oct;211(8):367-373. (PMID: 31441077) BMJ. 2013 Jun 21;346:f3443. (PMID: 23794316) Rev Bras Hematol Hemoter. 2015 Nov-Dec;37(6):400-5. (PMID: 26670403) Cochrane Database Syst Rev. 2015 Jul 22;(7):CD004736. (PMID: 26198451) BJOG. 2016 Dec;123(13):2087-2093. (PMID: 27533357) BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884) BJOG. 2016 Sep;123(10):1654-62. (PMID: 26969482) BMJ Open. 2021 Nov 23;11(11):e053288. (PMID: 34815287) Am J Clin Nutr. 2000 Jul;72(1 Suppl):257S-264S. (PMID: 10871591) Gates Open Res. 2021 Dec 7;5:174. (PMID: 35492865) |
فهرسة مساهمة: | Keywords: Anemia; Birth weight; Iron; Iron-deficiency; Pregnancy; RCT |
المشرفين على المادة: | E1UOL152H7 (Iron) 6897GXD6OE (ferric carboxymaltose) 0 (Hemoglobins) 0 (Ferric Compounds) 69-79-4 (Maltose) |
تواريخ الأحداث: | Date Created: 20240212 Date Completed: 20240214 Latest Revision: 20240214 |
رمز التحديث: | 20240214 |
مُعرف محوري في PubMed: | PMC10858019 |
DOI: | 10.12688/gatesopenres.14710.2 |
PMID: | 38343768 |
قاعدة البيانات: | MEDLINE |
تدمد: | 2572-4754 |
---|---|
DOI: | 10.12688/gatesopenres.14710.2 |