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)
- Author(s)
- Harding, R; Moya, E; Ataide, R; Truwah, Z; Mzembe, G; Mhango, G; Demir, AV; Stones, W; Randall, L; Seal, M; Johnson, K; Bode, S; Mwangi, MN; Pasricha, SR; Braat, S; Phiri, KS;
- Journal Title
- Gates Open Research
- Publication Type
- Protocol
- Abstract
- 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.
- Keywords
- Infant, Newborn; Child; Female; Humans; Pregnancy; Iron/therapeutic use; Pregnancy Trimester, Third; Pregnant Women; *Anemia, Iron-Deficiency/drug therapy; *Anemia/drug therapy; Hemoglobins/analysis; Malawi/epidemiology; Randomized Controlled Trials as Topic; *Ferric Compounds; Maltose/*analogs & derivatives; Anemia; Birth weight; Iron; Iron-deficiency; Rct
- Department(s)
- Clinical Haematology
- PubMed ID
- 38343768
- Publisher's Version
- https://doi.org/10.12688/gatesopenres.14710.2
- Open Access at Publisher's Site
https://doi.org/10.12688/gatesopenres.14710.2- Terms of Use/Rights Notice
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Creation Date: 2024-08-20 06:08:18
Last Modified: 2024-08-20 06:56:56