دورية أكاديمية
أعرض في EDS

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).

التفاصيل البيبلوغرافية
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
الوصف
تدمد:2572-4754
DOI:10.12688/gatesopenres.14710.2