SEARCHRCTobstetrics and gynecology, hematology

RCT·obstetrics and gynecology, hematology, clinical nutrition, micronutrients, minerals·PMC10193370

Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial

Lancet (London, England) · 16 authors, 11 centres

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TL;DR

In a randomised controlled trial of 862 anaemic pregnant women in Malawi, a single intravenous dose of ferric carboxymaltose did not significantly reduce anaemia at 36 weeks' gestation compared with standard oral iron, and did not increase birthweight.

Full summary

726 CHARS

This open-label, individually randomised controlled trial enrolled 862 anaemic pregnant women in southern Malawi and assigned them 1:1 to a single intravenous dose of ferric carboxymaltose (n=430) or standard-of-care oral iron at 60 mg elemental iron twice daily for 90 days (n=432), both groups receiving intermittent preventive malaria treatment. The primary maternal outcome was anaemia at 36 weeks' gestation, and the primary neonatal outcome was birthweight. Ferric carboxymaltose did not reduce anaemia prevalence at 36 weeks (52% vs 57%; PR 0·92, 95% CI 0·81–1·06; p=0·27). Birthweight did not differ between groups. There were no infusion-related serious adverse events or differences in adverse events by organ class.

STUDY TYPE

RCT

SPECIALTY

obstetrics and gynecology

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100% · A

ORIGINAL PAPER

PMC10193370

Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial

Lancet (London, England)

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ABSTRACT

Summary Background Anaemia affects 46% of pregnancies in Africa; oral iron is recommended by WHO but uptake and adherence are suboptimal. We tested a single dose of a modern intravenous iron formulation, ferric carboxymaltose, for anaemia treatment in Malawian pregnant women. Methods In this open-label, individually randomised controlled trial, we enrolled women with a singleton pregnancy of 13–26 weeks' gestation in primary care and outpatient settings across two regions in southern Malawi. Women were eligible if they had capillary haemoglobin of less than 10·0 g/dL and negative malaria rapid diagnostic test. Participants were randomised by sealed envelope 1:1. Assessors for efficacy outcomes (laboratory parameters and birthweight) were masked to intervention; participants and study nurses were not masked. Participants were given ferric carboxymaltose up to 1000 mg (given once at enrolment in an outpatient primary care setting), or standard of care (60 mg elemental iron twice daily for 90 days), along with intermittent preventive malaria treatment. The primary maternal outcome was anaemia at 36 weeks' gestation. The primary neonatal outcome was birthweight. Analyses were performed in the intention-to-treat population for mothers and liveborn neonates, according to their randomisation group. Safety outcomes included incidence of adverse events during infusion and all adverse events from randomisation to 4 weeks' post partum. The trial is registered with ANZCTR, ACTRN12618001268235. The trial has completed follow-up. Findings Between Nov 12, 2018, and March 2, 2021, 21 258 women were screened, and 862 randomly assigned to ferric carboxymaltose (n=430) or standard of care (n=432). Ferric carboxymaltose did not reduce anaemia prevalence at 36 weeks' gestation compared with standard of care (179 [52%] of 341 in the ferric carboxymaltose group vs 189 [57%] of 333 in the standard of care group; prevalence ratio [PR] 0·92, 95% CI 0·81 to 1·06; p=0·27). Anaemia prevalence was numerically lower in mothers randomly assigned to ferric carboxymaltose compared with standard of care at all timepoints, although significance was only observed at 4 weeks' post-treatment (PR 0·91 [0·85 to 0·97]). Birthweight did not differ between groups (mean difference –3·1 g [–75·0 to 68·9, p=0·93). There were no infusion-related serious adverse events or differences in adverse events by any organ class (including malaria; ≥1 adverse event: ferric carboxymaltose 183 [43%] of 430 vs standard of care 170 [39%] of 432; risk ratio 1·08 [0·92 to 1·27]; p=0·34). Interpretation In this malaria-endemic sub-Saharan African setting, treatment of anaemic pregnant women with ferric carboxymaltose was safe but did not reduce anaemia prevalence at 36 weeks' gestation or increase birthweight. Funding Bill & Melinda Gates Foundation (INV-010612).

CITATION EXPORT

Sant-Rayn Pasricha, Martin N Mwangi, Ernest Moya et al.. Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial. Lancet (London, England). (2023). https://doi.org/10.1016/S0140-6736(23)00278-7

AUTHORS

16 · 11 CENTRES

Sant-Rayn Pasricha, Martin N Mwangi, Ernest Moya, Ricardo Ataide, Glory Mzembe, Rebecca Harding, Truwah Zinenani, Leila M Larson, Ayse Y Demir, William Nkhono, Jobiba Chinkhumba, Julie A Simpson, Danielle Clucas, William Stones, Sabine Braat, Kamija S Phiri

aPopulation Health and Immunity Division, Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia
bDiagnostic Haematology, The Royal Melbourne Hospital, Parkville, VIC, Australia
cClinical Haematology, The Peter MacCallum Cancer Centre and The Royal Melbourne Hospital, Parkville, VIC, Australia
dDepartment of Medical Biology, University of Melbourne, Parkville, VIC, Australia
eDepartment of Medicine at the Peter Doherty Institute, University of Melbourne, Parkville, VIC, Australia
fCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Parkville, VIC, Australia
gTraining and Research Unit of Excellence, Blantyre, Malawi
hDepartment of Public Health, School of Public and Global Health, Kamuzu University of Health Sciences, Blantyre, Malawi
iThe Micronutrient Forum, Healthy Mothers Healthy Babies Consortium, Washington, DC, USA
jDepartment of Health Promotion, Education and Behavior, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA
kLaboratory for Clinical Chemistry and Haematology, Meander Medical Centre, Amersfoort, Netherlands