Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): study protocol for a randomised hybrid effectiveness-implementation trial.
Anaemia in pregnancy
Anaemia, iron deficiency
Cost-effectiveness
Depression
Ferric carboxymaltose
Ferrous sulphate
Implementation science
Pregnancy
Protocol
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
08 Sep 2022
08 Sep 2022
Historique:
received:
29
06
2022
accepted:
24
08
2022
entrez:
8
9
2022
pubmed:
9
9
2022
medline:
14
9
2022
Statut:
epublish
Résumé
Anaemia in pregnancy is highly prevalent in African countries. High-dose oral iron is the current recommended treatment for pregnancy-related iron deficiency anaemia (IDA) in Nigeria and other African countries. This oral regimen is often poorly tolerated and has several side effects. Parenteral iron preparations are now available for the treatment of IDA in pregnancy but not widely used in Africa. The IVON trial is investigating the comparative effectiveness and safety of intravenous ferric carboxymaltose versus oral ferrous sulphate standard-of-care for pregnancy-related IDA in Nigeria. We will also measure the implementation outcomes of acceptability, feasibility, fidelity, and cost-effectiveness for intravenous ferric carboxymaltose. This is an open-label randomised controlled trial with a hybrid type 1 effectiveness-implementation design, conducted at 10 health facilities in Kano (Northern) and Lagos (Southern) states in Nigeria. A total of 1056 pregnant women at 20-32 weeks' gestational age with moderate or severe anaemia (Hb < 10g/dl) will be randomised 1:1 into two groups. The interventional treatment is one 1000-mg dose of intravenous ferric carboxymaltose at enrolment; the control treatment is thrice daily oral ferrous sulphate (195 mg elemental iron daily), from enrolment till 6 weeks postpartum. Primary outcome measures are (1) the prevalence of maternal anaemia at 36 weeks and (2) infant preterm birth (<37 weeks' gestation) and will be analysed by intention-to-treat. Maternal full blood count and iron panel will be assayed at 4 weeks post-enrolment, 36 weeks' gestation, delivery, and 6 weeks postpartum. Implementation outcomes of acceptability, feasibility, fidelity, and cost will be assessed with structured questionnaires, key informant interviews, and focus group discussions. The IVON trial could provide both effectiveness and implementation evidence to guide policy for integration and uptake of intravenous iron for treating anaemia in pregnancy in Nigeria and similar resource-limited, high-burden settings. If found effective, further studies exploring different intravenous iron doses are planned. ISRCTN registry ISRCTN63484804 . Registered on 10 December 2020 Clinicaltrials.gov NCT04976179 . Registered on 26 July 2021 The current protocol version is version 2.1 (080/080/2021).
Sections du résumé
BACKGROUND
BACKGROUND
Anaemia in pregnancy is highly prevalent in African countries. High-dose oral iron is the current recommended treatment for pregnancy-related iron deficiency anaemia (IDA) in Nigeria and other African countries. This oral regimen is often poorly tolerated and has several side effects. Parenteral iron preparations are now available for the treatment of IDA in pregnancy but not widely used in Africa. The IVON trial is investigating the comparative effectiveness and safety of intravenous ferric carboxymaltose versus oral ferrous sulphate standard-of-care for pregnancy-related IDA in Nigeria. We will also measure the implementation outcomes of acceptability, feasibility, fidelity, and cost-effectiveness for intravenous ferric carboxymaltose.
METHODS
METHODS
This is an open-label randomised controlled trial with a hybrid type 1 effectiveness-implementation design, conducted at 10 health facilities in Kano (Northern) and Lagos (Southern) states in Nigeria. A total of 1056 pregnant women at 20-32 weeks' gestational age with moderate or severe anaemia (Hb < 10g/dl) will be randomised 1:1 into two groups. The interventional treatment is one 1000-mg dose of intravenous ferric carboxymaltose at enrolment; the control treatment is thrice daily oral ferrous sulphate (195 mg elemental iron daily), from enrolment till 6 weeks postpartum. Primary outcome measures are (1) the prevalence of maternal anaemia at 36 weeks and (2) infant preterm birth (<37 weeks' gestation) and will be analysed by intention-to-treat. Maternal full blood count and iron panel will be assayed at 4 weeks post-enrolment, 36 weeks' gestation, delivery, and 6 weeks postpartum. Implementation outcomes of acceptability, feasibility, fidelity, and cost will be assessed with structured questionnaires, key informant interviews, and focus group discussions.
DISCUSSION
CONCLUSIONS
The IVON trial could provide both effectiveness and implementation evidence to guide policy for integration and uptake of intravenous iron for treating anaemia in pregnancy in Nigeria and similar resource-limited, high-burden settings. If found effective, further studies exploring different intravenous iron doses are planned.
TRIAL REGISTRATION
BACKGROUND
ISRCTN registry ISRCTN63484804 . Registered on 10 December 2020 Clinicaltrials.gov NCT04976179 . Registered on 26 July 2021 The current protocol version is version 2.1 (080/080/2021).
Identifiants
pubmed: 36076211
doi: 10.1186/s13063-022-06690-2
pii: 10.1186/s13063-022-06690-2
pmc: PMC9454388
doi:
Substances chimiques
Ferric Compounds
0
Iron
E1UOL152H7
Banques de données
ClinicalTrials.gov
['NCT04976179']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
763Subventions
Organisme : Bill and Melinda Gates Foundation
ID : (Investment ID INV-017271)
Informations de copyright
© 2022. The Author(s).
Références
Value Health. 2010 Jan-Feb;13(1):8-13
pubmed: 19883405
BJOG. 2019 May;126(6):737-743
pubmed: 30554474
BMC Pregnancy Childbirth. 2018 Aug 28;18(1):349
pubmed: 30153811
BMJ Glob Health. 2017 Jul 28;2(2):e000310
pubmed: 29081998
J Psychiatr Res. 2020 Mar;122:88-96
pubmed: 31945502
PLoS One. 2021 Apr 14;16(4):e0249789
pubmed: 33852614
Afr J Reprod Health. 2011 Dec;15(4):33-41
pubmed: 22571103
Lancet Glob Health. 2021 Feb;9(2):e189-e198
pubmed: 33245866
Lancet. 2011 Dec 17;378(9809):2123-35
pubmed: 21813172
Gastroenterol Hepatol (N Y). 2015 Apr;11(4):241-50
pubmed: 27099596
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
Niger J Clin Pract. 2020 Jul;23(7):889-896
pubmed: 32620715
Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78
pubmed: 17666600
Malar J. 2020 Nov 7;19(1):393
pubmed: 33160357
Hum Antibodies. 2020;28(1):11-19
pubmed: 31282410
Implement Sci. 2017 Aug 29;12(1):108
pubmed: 28851459
J Perinat Med. 2017 May 24;45(4):443-453
pubmed: 27278921
BMC Pregnancy Childbirth. 2019 Feb 4;19(1):54
pubmed: 30717690
Lancet Haematol. 2020 Apr;7(4):e342-e350
pubmed: 32220343
PLoS One. 2020 Jan 23;15(1):e0227965
pubmed: 31971986
Niger Postgrad Med J. 2020 Apr-Jun;27(2):67-75
pubmed: 32295935
Semin Hematol. 2018 Oct;55(4):223-234
pubmed: 30502851
J Perinatol. 2019 Apr;39(4):519-532
pubmed: 30692612
Implement Sci. 2009 Aug 07;4:50
pubmed: 19664226
J Acquir Immune Defic Syndr. 2016 Aug 1;72 Suppl 2:S161-6
pubmed: 27355504
BMC Pregnancy Childbirth. 2014 Mar 25;14:115
pubmed: 24667031
Reprod Health. 2018 Jun 22;15(Suppl 1):96
pubmed: 29945649
J Obstet Gynaecol Can. 2018 Jun;40(6):698-703
pubmed: 29307706
Med Care. 2012 Mar;50(3):217-26
pubmed: 22310560
Biomed Res Int. 2014;2014:849080
pubmed: 24982910
BMC Pregnancy Childbirth. 2018 Oct 11;18(1):400
pubmed: 30314455
Lancet. 2018 May 12;391(10133):1927-1938
pubmed: 29550029
J Obstet Gynaecol. 2006 Nov;26(8):773-6
pubmed: 17130028
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
Health Policy Plan. 2021 Feb 16;35(10):1339-1346
pubmed: 33230561
J Biomed Inform. 2019 Jul;95:103208
pubmed: 31078660
Lancet Glob Health. 2018 May;6(5):e548-e554
pubmed: 29571592
Public Health Nutr. 2021 Aug;24(12):3648-3661
pubmed: 33190664
Anemia. 2020 May 08;2020:1915231
pubmed: 32455008
J Nepal Health Res Counc. 2017 Sep 08;15(2):96-99
pubmed: 29016575
Medicine (Baltimore). 2016 Jan;95(2):e2308
pubmed: 26765407
Am J Perinatol. 2019 Mar;36(4):366-376
pubmed: 30121943
Niger J Physiol Sci. 2017 Mar 06;31(2):121-125
pubmed: 28262847